Section 201(h) of the Food, Drugs, and Cosmetics Act defines a medical device as any healthcare product that does not achieve its principal intended purposes by chemical action or metabolized.
The FDA approval of an IDE is required for US human study of a significant risk device that is not approved for the study's indication.
Device trials are unique.
Background of medical issue, the study goals, and why this study will further the science.
Should include:
Discussion of the appropriateness of endpoint parameters, hypotheses, and success criteria
Should evaluate the safety and effectiveness of the device in the population expected to be indicated.
Driven by either:
The minimum number of patients and/or minimum duration of follow-up may be required depending on:
Generally used to evaluate additional meaningful claims.
One size does not fit all for device trials. Pivotal studies should be designed to evaluate whether there is a “reasonable assurance of safety and effectiveness.” PMA approbation is based upon a Benefit-Risk assessment that strongly considers the outcome of primary safety and effectiveness endpoints. Secondary endpoints are generally used to support claims if the primary endpoints are successful. All endpoint analyses and definitions should be clearly pre-specified in the approved clinical protocol.
Medical products are safer and more effective for everyone when clinical research includes diverse populations.
Sec. 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA) directed FDA to investigate how well demographic subgroups (sex, age, race, and ethnicity) in applications for medical products — drugs, biologics, and devices, submitted to the agency for marketing approval:
1) Are included in clinical trials; and
2) If subgroup-specific safety and effectiveness data are available.
It is important to test drugs and medical products in the people they are meant to help. The FDA works to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials. The links below provide information on different populations and their involvement in clinical trials for medical products.
The Office of Minority Health is leading groups made up of many FDA centers to develop actions to reduce health disparities.
More Information on Diversity in Clinical Trials
Ontario is a known leader in conducting innovative clinical trials, and the clinical trials community in Ontario has proven this strength throughout the COVID-19 pandemic. One innovative trial underway in Ontario is Vielight Inc.’s COVIDlight trial, which tests whether the recovery of COVID-19 patients may be accelerated by the use of a specialized light therapy device. This trial was made possible in part by Clinical Trials Ontario’s Trial Site Network through a connection made between Vielight Inc. and Impact Clinical Trials. CTO spoke with representatives from Vielight and Impact Clinical Trials about their trial and their experience with the Trial Site Network.
Vielight Inc. has developed a compact and portable device named the “Vielight RX Plus,” based on the science of photobiomodulation (PBM). PBM uses certain light energy to modify cellular functions and can play a role in the management of COVID-19. This clinical trial assesses the efficacy of the Vielight RX Plus to reduce symptom duration and severity in patients suffering from COVID-19.
The Vielight RX Plus device delivers light therapy to the sternum and the nasal canal.
“This device brings a holistic approach to the treatment of COVID-19 patients,”
said Nazanin Hosseinkhah, Research Scientist and Physicist at Vielight Inc.
“The device stimulates the thymus gland, creates nitric oxide, increases natural killer cells, acts as an anti-inflammatory therapy, and increases cellular energy.”
This unique, at-home study has the potential to modulate immune cell and cytokine activity in COVID-19 patients with an easy to use the device.
“We are very hopeful that this trial will prove to help patients recover from COVID-19 at home, and result in less burden to the healthcare system,”
said Hosseinkhah.
This randomized controlled trial, being managed by Impact Clinical Trials, is actively recruiting 280 participants who are confirmed to have contracted COVID-19. The trial was authorized by Health Canada in early September and is recruiting participants in Ontario and the United States. Participants are allocated into a treatment or a control group, with 140 participants randomized to receive the Vielight RX Plus device and the other 140 participants receiving the current standard of care. The trial is conducted remotely with non-hospitalized participants.
Participants in the treatment group receive the device by courier within 24 hours of registering for the trial. They are asked to place the device on their chest and onto their nostril for 20 mins each day. They then track their symptoms within a daily survey over a 30-day period.
“This is a simple, at-home study for participants to be involved in,”
said Andrea Berk from Impact Clinical Trials.
“Participants in both the treatment and the control groups are completely supported throughout the trial, with a 24-hour number they can call if they have any questions.”
This trial was made possible in part by a connection made directly through CTO’s Trial Site Network. The Trial Site Network, part of CTO’s Industry Concierge program, comprises more than 230 sites. The Network allows CTO to provide warm introductions to Ontario’s hospitals, research institutions, private research networks, and CROs.
“We have been able to guide companies such as Vielight in getting their trials up and running in Ontario,”
said Andrew Haller.
“I was introduced to Andrew Haller from CTO a few months before the COVID-19 pandemic,”
said Berk.
“Pre-COVID I was working on half a dozen connections that had been made through the Trial Site Network. When COVID-19 hit, those projects were put on hold. I reached out to Andrew to let him know Impact Clinical Trials had the consulting capacity, and that is when he introduced us to Vielight.”
Haller knew that Vielight had been searching for someone to take on the management of their clinical trial. “When Andrew introduced us to Andrea Berk from Impact Clinical Trials, we immediately connected and knew they were the right fit,” said Hosseinkhah.
An industrial designer develops the concepts for manufactured products, such as machines, medical devices, toys, electronics, and more. They combine art, business, and engineering to make products that people use every day. They work in offices in a variety of industries. Although they design manufactured products, only about 29% of industrial designers are employed directly by manufacturers.
An industrial designer will typically do the following:
Industrial designers generally focus on a particular product category. For example, some design medical equipment, while others work on consumer electronics products. Other designers develop ideas for new bicycles, furniture, housewares, or snowboards. They imagine how consumers might use a product and test different designs with consumers to see how each design looks and works.
Industrial designers often work with engineers, production experts, and marketing specialists to find out if their designs are feasible and to apply their colleagues’ professional expertise to their designs. For example, industrial designers may work with marketing specialists to develop plans to market new product designs to consumers.
Original article from careerexplorer.com
In his book The Sciences of the Artificial, Herbert Simon started what we now refer to as design thinking. Since then, numerous other works have been published detailing design thinking concepts and how it relates to all manner of different business models. One of the most famous icons to design thinking in the modern era is probably Apple, Inc. Let’s ask ourselves:
· Did you feel you needed an iPod before Apple created?
· Did you feel you needed an iPhone before Apple created it?
Apple’s genius during the early 2000s was not in creating new products that no one had ever heard of. There were dozens of cell phone manufacturers making quality cell phones before the iPhone landed. There were dozens of MP3 players on the market before the original iPod.
But, once Apple entered the arena, none of that mattered. Why? Because Apple understood the unarticulated needs (and in fact, you could even argue that Apple’s real genius was creating a need for a product by releasing that product!) of its customers. How were they able to do this?
How can we solve a problem for our customer in such a way that they don’t even know the problem exists until we show the solution?
Design thinking is a process of five distinct phases of execution. Those phases are:
· Empathize
· Define
· Ideate
· Prototype
· Test
Looking at that list, it seems to be a mix of skills from various disciplines. “Prototype” and “test” seem to be drawn from engineering and product development, whereas “empathize” and “ideate” come from a more psychological, social methodology.
Empathizing immediately sets design thinking apart from most of the other business models out there. True, most business models strive to understand their ideal client’s needs and wants, but few do it from a relational perspective. This is what Simon Sinek talks about in his book Start With Why: That people don’t buy what you do, they buy why you do it. For Apple, that meant understanding the desire of their customers to be a part of something. They weren’t buying things because it was the best. They were buying it because of the reasons behind WHY Apple made it. When the corporate world was turning its back on customer relations and focused more on profits than on value, Apple communicated a different mission and mindset, which allowed their sales to skyrocket.
Another crucial part of design thinking. The problem. The majority of creators will fail at this part because they think about problems as nouns. Problems are verbs. If you see a little girl trying to get cookies from the shelf, people will start listing the problems as:
· She needs a cookie
· She needs an adult
· She needs a ladder
· Maybe she needs milk with those cookies
While the truth is, she needs to reach. Reaching is the problem, not the cookies. If you solve the reaching problem, you solve anything she will want to reach in the future. Once we understand others' unarticulated needs through authentically empathizing, it’s time to define the problem.
Ideation, the process of coming up with potential solutions to your customers’ unarticulated needs, can only occur after those needs have been identified through empathy and the problem defined. Do we solve the problem through a product, or a relationship, or a service? Is it through expanding our business model to include other forms of retail or consumer service? As an operations manager, the unarticulated needs that I wasn’t meeting for my fellow workers were found in the way I was focused on problems, not on them personally. I felt like, and if nothing was going wrong, there was nothing for me to do. What was going on underneath the surface, and what I was failing to do, was to spend time with them, to learn their processes to the point that I could spot potential problems before they actually became problems. Again, this human-centered approach must consider, above all else, the user's experience, whether customer, employee, or client.
Prototyping doesn’t necessarily have to involve models or scaled-down products. Prototyping also applies to non-physical solutions as well, in terms of how we construct frameworks to solve problems. Obviously, there are times when physical prototyping is important, but the overarching goal of prototyping is to apply solutions in a controlled environment to allow for testing, the fifth phase.
The final and simplest phase of design thinking. Since design thinking doesn’t flow like time in a strictly linear fashion between stages, there are times when prototyping leads back to ideation and when defining the problem actually requires more time spent empathizing to reassess the customer’s needs. Because of this frequently recursive nature, by the time we arrive at the design thinking process's final phase, sometimes testing merely confirms the last step in our solution. Other times, it can restart the entire process from the beginning. The importance of moving fluidly throughout all five phases.
Creativity is about doing, not thinking. Design thinking as well is about playing and acting. Those actions will swing between a process-oriented approach and a human-oriented approach depending on the project. At the end of it all, whether we are talking about coworkers or customers, the one thing they all have in common is that they are people looking for solutions to their problems. Solving the problem without addressing the people will only lead to frustration and failure. Providing a solutions-based approach to problems rather than a problems-based approach to problems will guarantee a greater chance of lasting implementation and effectiveness of whatever problem we’re solving.
· https://www.ideou.com/pages/design-thinking
· https://www.creativityatwork.com/design-thinking-strategy-for-innovation/
· https://dschool.stanford.edu/resources-collections/a-virtual-crash-course-in-design-thinking
· https://www.interaction-design.org/literature/article/5-stages-in-the-design-thinking-process
· https://hbr.org/2008/06/design-thinking
Here is the official FDA regulation for design controls pertaining to design inputs, as found in Part 820.30(c):
Each manufacturer shall establish and maintain procedures to ensure that design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.
ISO 13485:2016 also covers this topic in section 7.3.3 Design and Development Inputs:
Inputs relating to product requirements shall be determined and records maintained. These inputs shall include:
a) functional, performance, and safety requirements, according to the intended use,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs,
d) other requirements essential for design and development, and
e) output(s) of risk management
These inputs shall be reviewed and approved.
Requirements shall be complete, unambiguous, and not in conflict with each other.
There are several terms used interchangeably when referring to design inputs:
Medical device product development should be a holistic process that builds upon itself as the project progresses.
Rushing the product to the market isn’t a recommended best practice in medical device development. Spending time in design inputs will really benefit your project. In device development, establishing design inputs can easily take up to 20% of the entire project timeline.
Writing design inputs takes practice and dedication. Also, design inputs should not just be the responsibility of one person. It’s a team effort. When a team is involved, you get the benefit of everyone’s opinions and experience.
You also should consider all sorts of other sources to help you define design inputs:
It’s important to remember that user needs should be established first in order to inform design inputs. Your goals when defining design inputs include:
You have to consider all types of sources and resources for design inputs. Your design inputs need to be comprehensive, covering all aspects of your medical device.
Today's customers expect nothing less than products of the highest quality, and it is incumbent on all manufacturers to assure this expectation is met. A proven technique for checking whether a manufacturing process is in control is a manufacturing audit.
A manufacturing audit is a comprehensive inspection of a process to determine whether it is performing satisfactorily. A manufacturing audit is usually limited to a small portion of units produced, but the manufacturing processes involved are reviewed thoroughly. An audit does not replace normal quality control efforts, but supplements them.
Medical audit is a systematic approach to peer review of medical care in order to identify opportunities for improvement and provide a mechanism for realizing them. Medical audit and clinical audit are often used interchangeably, but clinical audit might be considered to cover all aspects of clinical care-for example, nursing and the role of paramedical staff-whereas medical audit relates to practices initiated directly by doctors. It complements and may partly overlap financial audit, utilization review, and management of resources, but is primarily clinical, not managerial; its focus is the process and results of medical care rather than the use of resources and it is the responsibility of doctors rather than managers.
There are many reasons for conducting a manufacturing audit:
Kaiyan Medical got another audit supplier recognition by Made-in-China. We like to keep our audits and quality standards to the top in order to assure the best experience for our customers and clients
https://www.bmj.com/content/bmj/299/6697/498.full.pdf
In collaboration with the work of Jon Speer in July 19, 2020
Every industry in the world uses acronyms, and the overlap between multiple fields can be a source of confusion for professionals. There’s no room for confusion in the medical device industry, as a miscommunication could potentially lead to a product defect or adverse event with serious consequences.
Here the list:
Part 11 of Title 21 in the Code of Federal Regulations, commonly referred to as 21 CFR Part 11 or Part 11 for shorthand, establishes the acceptance criteria by FDA of electronic records, electronic signatures and handwritten signatures executed to electronic documents.
Compliance of quality systems with 21 CFR Part 11 requirements applies to the medical device industry, in addition to pharmaceutical, biotechnology, and other FDA-regulated industries.
FDA maintains quality system regulations, or QSR, found in 21 CFR Part 820, which establishes the quality system requirements for all medical device manufacturers in the United States. Manufacturers are required to establish and maintain a quality system that is appropriate for the medical device to ensure both the safety and efficacy for its intended use, per the requirements of 21 CFR Part 820.
A 483 observation, or “inspectional observation,” is a notice issued by an FDA inspector to flag potential regulatory violations found during a routine inspection. A Form 483 observation may be issued regarding any violation under FDA jurisdiction. Failure to demonstrate handling of the observed problems can be escalated to a warning letter.
A 510(k) is a regulatory premarket submission made to FDA for a Class I, II, or III medical device that doesn’t otherwise require premarket approval. The purpose of a 510(k) submission must demonstrate a safe and effective device that is substantial equivalent to an existing legally marketed device.
Application Lifecycle Management, or ALM, involves the specification, design, development and testing of software tools. ALM systems are used to manage quality and demonstrate compliance during the software delivery process.
An Auditing Organization, or AO, is responsible for auditing medical device manufacturers to evaluate conformity with quality management system requirements and other medical device regulatory requirements. An AO may be an independent organization or a Regulatory Authority (RA).
AOs participating in the Medical Device Single Audit Program (MDSAP) may conduct a single regulatory audit of a manufacturer which satisfies the relevant requirements of RAs participating in MDSAP.
An Approved Supplier List, or ASL, is an internal list kept by medical device manufacturers to record suppliers known to meet the quality and performance standards of the manufacturing organization.
A Bill of Materials, or BOM, is a complete list of raw materials, assemblies, and subassemblies required to produce a device, as well as the quantities required for each. A BOM is required to carry out change management processes for a medical device.
A Competent Authority, or CA, is a body within the government of a Member State in the European Union. A CA transposes the requirements of Europe's medical device regulation (MDR) into the national law of each Member State. For example, the Federal Institute for Drugs and Medical Devices (BfArM) is the the CA for Germany.
A Conformity Assessment, or CA, is carried out by an EU Notified Body to determine that a medical device is safe and performs as intended by the manufacturer. Medical devices must pass a conformity assessment in order to obtain CE Marking.
Computer-Aided Design (CAD) software allows device manufacturers and designers to draft detailed designs, including precise specifications and measurements. CAD software files can be stored on a digital database for reference.
Corrective and Preventive Action, or CAPA, is a quality system process carried out by a medical device organization to reduce and/or eliminate potential sources of risk and regulatory non-conformance or noncompliance.
A CE Marking, or CE Mark, certification must be obtained by medical device manufacturers for product distribution into the European Union (EU) marketplace. CE Marks are issued by third-party organizations, known as a Notified Bodies, and indicate compliance with the applicable EU medical device regulations (MDR).
The European Committee for Standardization, or CEN, is a public standards organization that develops standards for medical devices for sale in the European Union (EU). CEN can be compared to the Food and Drug Administration (FDA), which maintains and enforces medical device regulations in the U.S. marketplace.
The Center for Devices and Radiological Health, or CDRH, is a branch of the U.S. Food and Drug Administration (FDA) responsible for overseeing the approval of medical devices for sale in the U.S. market and also monitors the manufacturing, performance, and safety of those medical devices.
A Clinical Evaluation Report, or CER, provides clinical evidence that a medical device will perform as expected, such that no safety issues occur while using it. European regulations require medical device manufacturers to perform a conformity assessment, of which include CER documentation, in order to legally market a product in the EU.
Cost of Quality, or CoQ, is a system for measuring the financial impact that a quality system and its processes has on a business. Medical device companies can use CoQ to calculate potential savings and weigh those against the costs associated with internal process improvements.
Computer System Validation, or CSV, is a process used to demonstrate that computer systems, including hardware and software, used in medical device manufacture meet the regulations outlined in 21 CFR Part 11.
Current Good Manufacturing Practices, or cGMP, are minimum standards provided by FDA for manufacturing processes and facilities. The FDA cGMP standards establish a framework for medical device manufacturers to follow and allow for greater flexibility in achieving various quality requirements.
A Document Change Order, or DCO, is a formalized process in medical device change management. The DCO process involves change requests to be made within an organization to a document or system in a standardized, traceable manner.
The De Novo regulatory pathway is a classification process that uses a risk-based methodology for novel medical device to be granted market entry for sale in the U.S. For a de novo submission to be granted by FDA, general controls must indicate that the device is safe and effective for its intended use.
The Deming Cycle is a methodology for monitoring quality efficacy and serves as a basis for traditional quality assurance. The Deming Cycle model is comprised of four parts: plan, do, study, and act. These parts are often summarized as PDSA.
Design Controls or DC, as defined by FDA in 21 CFR 820.30, are a systematic process that ensures specific design requirements are met by documented procedures that control the design of the medical device. The purpose of DCs is to demonstrate that a medical device is safe, effective, and performs as expected.
A Design Dossier, or DD, includes all contents of the technical file (TF), which describe a device’s design, manufacturing, and performance, as well as the documentation that demonstrates conformity with applicable regulatory requirements.
A Design of Experiment, or DoE, is a method for medical device manufacturers and engineers to validate internal processes and predict process variability in order to improve and maintain product quality.
A Design for Manufacture, or DFM, is a process for optimizing the design of a medical device for manufacturing. A DFM takes into account the cost of manufacture, as well as regulatory compliance and product performance.
A Design History File, or DHF, contains all documentation related to the design and development of a medical device. Medical device manufacturers in the U.S. market are required by law under FDA 21 CFR Part 820 to maintain a DHF.
The Device History Record, or DHR, acts as a record of production for a medical device and demonstrates it was manufactured according to information stored in the device master record (DMR). Manufacturers operating in the U.S. are required under CFR Part 820.184 to maintain a DHR, which contains information such as acceptance records for units or batches of products, unique product identifiers, and product counts.
A Device Master Record, or DMR, is a record of all the information and specifications required to produce a medical device. The DMR contains instructions for manufacturing, drawings and specifications for devices, and requirements for labeling and packaging. Manufacturers are required by FDA to maintain a DMR under CFR Part 820.181.
A Document Management System, or DMS, is a tool used to store and manage documents related to medical device development, as well as track any changes made to documents throughout the product lifecycle on an ongoing basis. A DMS is not synonymous with a Quality Management System, or QMS, which stores documents but also has a regulatory compliance focus.
An Engineering Change Order, or ECO, is a process that is triggered when an issue is raised with a medical device in terms of performance, cost-effectiveness, or the process of manufacturing the device. An ECO is typically followed by an analysis to determine whether action should be taken. Depending on the nature of the change, an ECO may lead to a CAPA investigation.
An Establishment Inspection Report, or EIR, is made by FDA in the event a Form 483 is issued following an inspection. The next steps after receiving an official EIR from FDA will be determined by the severity of the issues observed, as well as the 483 response. If significant deficiencies are observed, FDA may decide to issue a warning letter.
Enterprise Resource Planning, or ERP, refers to the management of business processes within the organization of a medical device organization. This is often carried out with the use of ERP tools that gather and organize business data and automate processes related to human resources and business practices.
The European Commission's new IVDR 2017/746, which is shorthand for In Vitro Diagnostic Regulation, is Europe's new regulation for in vitro diagnostic devices that is scheduled to go into effect 26 May 2022. The IVDR requires all existing IVD devices being sold in the EU market to undergo recertification for compliance with the new requirements, which supersede the previously held directives for in-vitro diagnostic devices (IVDD).
MDD is the Medical Device Directive for medical devices sold in the European marketplace, which was replaced in 2017 by the medical device regulation (MDR. The purpose of the directive was to harmonize laws and standards around medical devices marketed in the European Union.
EU MDR is a common abbreviation for the medical device Regulation (EU) 2017/745, which mandates the quality and safety requirements for medical devices produced and marketed in the European Union (EU). The EU medical device regulation supersedes the previously held medical device directives (MDD) that were in place up until 2017 and places strong emphasis on a total product lifecycle approach.
The European Database on Medical Devices, or EUDAMED, is a database developed by the European Commission to facilitate compliance with European medical device regulations. It's intended to function as a multipurpose system for registration, collaboration, and communication for multiple stakeholders in the medical device industry.
The Food and Drug Administration, or FDA, is a federal agency of the U.S. Department of Health and Human Services. The FDA is responsible for approving medical devices for manufacture and distribution within the U.S. Medical device manufacturers operating within the U.S. market are subject to FDA inspections and compliance with the requirements outlined in Title 21 of the Code of Regulations.
Failure Modes and Effects Analysis, or FMEA, is a method used to identify failures in a design or process associated with a medical device. FMEA is distinct from ISO 14971, the international standard for medical device risk management. The FMEA method can be broken into two parts: PFMEA for processes, and DFMEA for designs.
Fault Tree Analysis, or FTA, is an analytical method aimed at identifying points of failure and risk within a quality system. In medical device manufacture, FTA can be applied throughout the course of risk management activities to identify possible sources of risk.
Freedom to Operate, or FTO, refers to product infringement on intellectual property. Device manufacturers typically declare whether they have FTO in each market in which they plan to sell a new product.
Medical device manufacturers are required to comply with the General Safety and Performance Requirements (GSPRs) of the new EU MDR. The regulation splits GSPRs into three chapters, general requirements, requirements regarding design and manufacture, and requirements regarding the information supplied with the device.
Hazard Identification, or HID, is a risk management process in which device manufacturers determine whether situations, processes, or items associated with the production of their device may have the potential to cause harm.
An Investigational Device Exemption, or IDE, is an FDA exemption that allows an investigational device to be used for testing a device against premarket approval standards. An investigational device can be used to gather data on the safety and effectiveness of the device, and this data is submitted as an IDE for review by FDA.
IEC 60601 is a standard pertaining to electrical medical equipment. Any medical device containing electronics must pass the necessary requirements outlined in IEC 60601.
Programmable Electrical Medical Systems, or PEMS, is a key part of what's covered in IEC 60601. PEMS consists of software, firmware, and equipment that can be programmed to carry out functions that aid medical care or treatment. The standard also covers mechanical safety, labeling, and risk management.
IEC 62304 is a software framework that outlines software engineering and documentation practices. It is also recognized by FDA and provides a risk-based framework that can be used throughout entire medical device software lifecycle.
Instructions for Use, or IFU, are instructional materials used to convey relevant information to the end user. These materials must take into account the capabilities and limitations of the end user in order to communicate instructions as concisely and objectively as possible.
The International Medical Device Regulators Forum, or IMDRF, is a voluntary working group of international medical device experts whose purpose is to harmonize medical device standards and regulations. The IMDRF supersedes the Global Harmonization Task Force.
Installation Qualification, Operational Qualification, and Performance Qualification are terms that pertain to medical device software and equipment validation. IQ relates to the proper installment of software or equipment, OQ concerns meeting the necessary regulatory requirements, and PQ has to do with compliance of the software or equipment performance.
An Institutional Review Board, or IRB, is a body that oversees human medical research in the U.S. and ensures that the human rights of all subjects are protected. An IRB has the authority to approve or disapprove research or to request modifications to research practices.
The International Organization for Standardization, or ISO, is a non-governmental organization of experts providing voluntary international standards, based on the subject matter expertise of members, to enable and promote innovative solutions to worldwide challenges.
ISO 13485:2016 is the internationally harmonized standard for medical device quality management systems (QMS). To align with ISO 13485:2016, QMS contents should address the specific, applicable requirements outlined in the standard, in addition to the applicable regulatory requirements according to the markets where the medical device will be manufactured and marketed.
ISO 14971:2019 is the latest version of the international standard for medical device risk management. The globally recognized standard offers best practices for using a proactive approach to risk management throughout the entire lifecycle of a medical device.
ISO 9001 is an international standard that specifies the requirements for a quality management system. Belonging under the umbrella of the ISO 9000 standard, 9001 is the only one that offers a certification pathway for manufacturers. This standard assumes a specialized focus on ensuring users receive good-quality products and services.
IVD refers to In Vitro Diagnostic devices. As defined in IVDR (EU) 2017/746, IVD can describe devices or equipment “intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body.”
Manufacturer and User Facility Device Experience, or MAUDE, is a database for medical device electronic reporting (eMDR) submitted to the FDA by manufacturers, importers, device user facilities, health care professionals, patients, and consumers.
Medical Device Reporting, or MDR, refers to a surveillance tool maintained by FDA that is used to monitor the performance and safety of medical devices after being placed on the market. MDR provides voluntary reporting capabilities to both medical device manufacturers and consumers for public-use.
The Medical Device Single Audit Program, or MDSAP, is a program allowing medical device manufacturers to gain access into multiple global markets through one audit event. There are currently five active participating regions of MDSAP, including Australia, Brazil, Canada, Japan, and the United States.
Medical Device User Fee Amendments, or MDUFA, refers to changes made to the fee structure in which medical device companies are expected to pay to FDA in order to register their establishments and devices. These fees also apply to application or notification submissions made to the FDA.
A Medical Device Quality Management System, or MDQMS, is a quality management system built from the ground up for the medical device industry. Unlike a legacy QMS or ad hoc system, a MDQMS typically includes templates and workflows that align with medical device industry requirements and best practices.
Manufacturing Resource Planning, or MRP, is a way of compiling, organizing, and planning various activities carried out by a medical device manufacturer (or with any business). The method involves simulating hypothetical scenarios to ensure resources are being used effectively. This term has fallen out of use in recent years and may also be referred to as ERP.
A Notified Body, or NB, is a third-party auditing organization that assesses the quality and conformity of medical device products seeking market entry into the European Union.
A Nonconformance Report, or NCR, is used to document non-conforming material observed during quality control activities or inspection. A NCR details the identified issue(s) of nonconformance, the severity and impact of the non-conformance, how it occurred, and how nonconformance will be managed to prevent recurrence.
Nonsignificant Risk, or NSR, is a measure of risk as outlined by ISO 14971. Determining whether a risk is significant or nonsignificant involves assessing the probability of direct harm, probability of harm from not using the device, and probability of harm from misinformation.
Own Brand Labeling, or OBL, occurs when a manufacturer sells a medical device in the EU that already has a CE Marking and does so under its own brand.
An Original Equipment Manufacturer, or OEM, is an organization that produces goods which are used as subparts in products of a third-party company, which then sells the end products to consumers.
The European Commission requires manufacturers to designate at least one person with the requisite expertise in the field of medical devices from within their organization as the Person Responsible for Regulatory Compliance (PRRC).
Product Development, or PD, is the pre-market process of building a medical device. In the medical device industry, this process encompasses the design and development of a product.
Product Data Management, or PDM, is the handling of data as it relates to a medical device within a software system. Modern medical device companies often use PDM tools to compile product data and automate management protocols.
In the manufacturing sector, Product Lifecycle Management, or PLM, is a system for managing and overseeing the development and distribution of a product. This process applies to the inception, design, regulatory approval, manufacturing, marketing, and post-market phases of medical devices until the product is no longer on the market.
Premarket Approval, or PMA, is the regulatory pathway to market required for Class III devices under FDA regulations. The PMA submission process typically involves clinical trials with human participants, as well as laboratory testing, to demonstrate the safety and efficacy of the device.
Post-Market Surveillance, or PMS, is the process of monitoring a medical device after it has gained market entry for sale and distribution of use for use by patients within the marketplace. PMS involves gathering data and feedback on the performance of a device on the market, and it is a mandatory process for compliance with most regulations and standards, including 21 CFR Part 820, EU MDR, and ISO 13485:2016.
Proof of Principle, or POP and also known as Proof of Concept, is the demonstration that the initial concept behind a medical device is feasible. The POP typically includes criteria for success that must be met in order to proceed with product development.
Production Planning and Control, or PPC, is a process used to organize the production, including design and development activities, and the manufacture of a medical device. A PPC process is usually comprised of inputs, outputs, and control systems. Regulations for design and development planning are found under FDA CFR 21 Part 820.30.
Quality Assurance, or QA, is a method used to prevent defective, nonconforming products. QA professionals engage in activities intended to improve the product development and testing processes, as well as maintaining compliant marketing and distribution processes.
A quality management system can be considered as a QA tool itself, as it serves as a single source of truth for all quality policies and procedures for the final product.
While QA focuses on the process, Quality Control, or QC, focuses on the product. QC is system for identifying defects in a medical device during the post-production phase, prior to product distribution. The goal of quality control is to ensure the product conforms to specified requirements and will meet expected performance criteria upon end user interface. QC and QA are complementary aspects of a QMS.
A Quality Management System, or QMS, is an organizational tool for implementing and maintaining activities, documents, and tasks as it relates to responsibilities, procedures, processes, and resources. A QMS is instrumental in achieving regulatory compliance and in producing safe and effective medical devices. At minimum, a quality system should include design controls, risk management, document control and records management, and supplier management.
The Quality System Inspection Technique, also known as the QSIT method, is a type of FDA inspection that uses a top-down approach to reviewing the four main subsystems within a company's QMS. The top-down approach used by the FDA inspector begins with reviewing the company's procedures before drilling down into the quality records for those processes. The quality records serve as proof the company is following its written procedures.
A Quality System Record, or QSR, is a record that acts as a source file for all documentation, procedures, and records that are located within a QMS. Medical device companies can use their QSR as a reference to navigate other aspects of their QMS. QSR can also refer to Quality System Regulation, shown below.
The Quality System Regulation, or QSR, for medical devices in the U.S. is outlined in FDA 21 CFR Part 820. The QSR requirements are based on methods for facilities, and controls used for, carrying out all phases of processes throughout the lifecycle of a medical device. These aspects include design, manufacture, packaging, labeling, storing, installing, and servicing of medical devices intended for use by humans.
Regulatory Affairs, or RA, professionals in the medical device industry play a strategic role throughout the product lifecycle, such as ownership of a company's go-to-market strategy for satisfying legal requirements of product commercialization, regulatory submission protocol, and postmarket surveillance methods. The RA role serves a critical function for effectively communicating and executing appropriate regulatory strategies to ensure compliance.
Risk Analysis, or RA, is a method used in risk management to identify specific risks associated with a design, procedure, or process used in the manufacture of a medical device. The RA process will include identifying the medical device, the persons involved, the scope of the risk analysis, and relevant date(s). Preliminary hazard analysis, FMEA, and fault tree analysis are all methods used to carry out risk analysis for a medical device.
Risk Management, or RM, is a process used by medical device companies to identify, control, and prevent hazards and risks/sources of harm that might arise during the use of a medical device. The internationally recognized standard for medical device RM processes are outlined in ISO 14971:2019.
Research Use Only, or RUO, is a term used to indicate that a medical device product or instrument does not have an intended medical purpose and instead is to be used for research purposes only. Devices used for research in IVD product development are often labeled RUO.
Software as a Medical Device, or SaMD, is a class of software used for medical functions, without needing a hardware component to serve that function. An application or software that's used to diagnose, cure, prevent, or mitigate disease are all considered to be classes of SaMD.
A Supplier Corrective Action Request, or SCAR, is a formal notice sent to a supplier by a medical device company upon the observance of issues related to nonconforming products or materials. Such issues impact the quality of the provided goods, and the purpose of the SCAR is to solicit action from the supplier to identify and correct the issue(s) raised.
Substantial Equivalence, or SE, is a regulatory requirement by FDA for market clearance of new products through a 510(k) premarket submission. To declare substantial equivalence, a company must prove their device is as safe and effective as a similar predicate device. SE is required for regulatory submissions for which a premarket approval (PMA) is not required.
The Safe Medical Devices Act, or SMDA, is a law which passed in 1990 establishing HHS as the governing authority over device user facilities to report incidents in which a medical device may have caused or contributed to the serious injury, illness, or death of a patient.
A Standard Operating Procedure, or SOP, is an internal procedure created by an organization to standardize a routine process for ease of repeatable. A SOP is typically a written document comprised of a series of prescriptive instructions to be followed by individuals and teams. Medical device companies are required to create and maintain SOPs for routine processes as part of their QMS.
Statistical Process Control, or SPC, is a method used to control a process through the use of statistical techniques. This involves compiling data from a process and building cause and effect models to predict and account for various outcomes.
Significant Risk, or SR, is a measure of risk as defined by ISO 14971. Any device that poses a serious risk to the health or safety of a human subject is categorized as SR.
Single-Use Devices, or SUDs, are disposable devices intended to be used for a singular event or procedure for one patient only. These devices are to be disposed after use rather than sanitized and re-used.
Summary Technical Documentation, or STED, is format manufacturers can use to record required information about how a medical device was designed, developed, and manufactured for submission to a Regulatory Authority or Notified Body to demonstrate conformity. The STED format represents the documentation required for Technical Files.
A Technical File, or Design Dossier for Class III devices, includes specific details about a medical device's design, composition, intended use, function, and clinical evaluation. TF are a key requirement of obtaining CE marking for a device.
Unique Device Identification, or UDI, is a system established by the FDA to catalog and identify each individual device for sale in the U.S. market by assigning a custom identifier that can be read by both humans and machines. A UDI is distinct from a Universal Product Code (UPC), as the UDI is used to identify a medical device on the FDA website via the AccessGUDID portal.
A Universal Product Code, or UPC, is a code printed on retail packaging consisting of a barcode and a 12-digit number. The code can be used to track inventory for retailers and is considered to be an alternative tracking method to UDI, the official identification system used by FDA.
Verification and Validation, also known as V&V, are activities for testing and confirming whether a medical device meets the design procedures and is ready to be released for manufacture. Design verification ensures you designed the device correctly and design validation ensures you designed the correct device. These processes tend to involve careful tests, trials, and analyses.
Voluntary Action Indicated, or VAI, is a term used by the FDA in establishment inspection reports (EIR) to indicate regulatory action is not required, following the observance of objectionable conditions or practices during an inspection. On the contrary, Official Action Indicated (OAI) would indicate regulatory or administrative action is required by FDA to correct an issue found during an inspection.
A Warning Letter (WL) is an official notice made by FDA in response to regulatory violations that have been escalated from a 483 observation. Violations may include anything from wrongful claims about the device to missing design controls. A WL will provide a detailed explanation of the violation and what is required of companies for a corrective action plan.
Work in Progress, or WIP, is a term used to refer to partially finished goods in manufacturing or within a design history record (DHR). Inventory that has entered the manufacturing process and can no longer be classed as raw materials but is not yet a finished product is classed as WIP.
The information provided in this article is for educational purposes only and is not intended to support the safety or effectiveness of any medical device, or diagnose, treat, cure, audit, procedure, quality standard or prevent any disease.
