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
While you were taking a shower, you had this amazing idea of a medical product that could potentially become a pioneer of its own kind. After consideration, you’ve decided to jump into the innovative and adventurous world of the medical device industry. But then, the confusing question will arise — “What is a medical device?”. If you find yourself wondering about this, there’s no need to worry. We are here to guide you on this journey of medical devices.
Medical devices could range from simple contact lenses to prosthetic knee implants and medical devices with embedded software like pacemakers. A medical device could be the smallest medical apparatus to the most complex.
The big question is not what is a medical device? but who defines what a medical device is?
In the USA, all medical devices are defined and regulated by the food and drug administration (FDA). The center for devices and radiological health (CDRH) is the specific branch intended for medical devices. It has complete jurisdiction over it.
A medical device is not only a commodity in the market but is also a state-regulated healthcare product, to which the state’s accountability towards its people. What makes a product a medical device is if its features become congruent to that of the definition stated under the stipulations of the FDA.
A medical device is quite simply and plainly defined under Section 201(h) of the Food, Drug, and Cosmetic Act as:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
You must define the intended use of your product and its indications. Its intended use includes the purpose of your device while its indications describe the condition that it aims to treat, diagnose, or prevent. Once you have written down all these specifications, it will be easier to determine if your product meets the FDA’s definition of a medical device or not.
Your medical device should have a proper medical device classification. This classification should follow FDA guidelines as well. Classification also highly depends on the product’s intent and its indications for use. Changing your product’s user market affects the classification of your product as well. The higher the class number, the more stringent regulatory measures are required to ensure the safety and effectiveness of your device.
The FDA has the following classifications for a medical device:
This can be divided into devices that require general controls and those that have a special exemption. The exemption should be stated upon classification.
General controls can be found in the following sections of the FD&C Act:
2. Class II- general controls and special controls
The moderate risk that comes with Class II medical devices requires what is known as “special controls” since general controls alone are not enough. These special controls are relative to the context of each device.
Here’s a list of special controls that are usually device-specific:
3. Class III- general controls and premarket approval (PMA)
According to the FDA, Class III medical devices are those that are “intended to be used in supporting or sustaining human life or preventing impairment of human health.”
All devices that fall under this category are subject to what is known as premarket approval by the FDA. Premarket approval requires extensive experimental procedures and scientific pieces of evidence. It can come in the form of a clinical trial, to prove that the device will be safe for the users.
The definition could be confusing at times with other products such as pharmaceuticals, general wellness products, software products, or combination products
Mixed products
Combination products are a mix of products that have are different by nature. For instance, a combination product is a mixture of a drug and a device, a biologic and a drug, a biologic and a device, or a mix of all three together. Therefore, by definition, a stand-alone medical device cannot be a combination product.
Pharmaceuticals
Pharmaceuticals are medicines and are chemical in nature designed to engage and actively interact with the body’s system. Medical devices are by nature mechanical and work only if they are used correctly based on their indications for use. Pharmaceuticals either work or they don’t. However, Pharmaceutical products that do not work also do not qualify them as a medical device.
Health Software
Medical device software is defined as a “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” On the other hand, Section 520(o)(1)(B) of the FD&C (Food, Drug & Cosmetics) Act, states that “any other software intended “for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition is not a device under section 201(h) of the FD&C Act.”
Wellness products
According to CDRH, general wellness must meet the following:
Because of their generally low-risk nature, they need not be classified and regulated as a medical device under the FDA.
“What makes your products a Medical device?” can be shortened in two things:
These two are the prerequisites that you need to keep in mind as early as possible in the product development process of your potential medical device.
For more inquiries regarding audits, processes, ideation, and more don’t hesitate in contacting us.
References:
https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health
https://www.fda.gov/medical-devices/overview-device-regulation/regulatory-controls#gen
https://www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber
https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder
https://www.fda.gov/about-fda/fda-organization/center-veterinary-medicine
https://www.fda.gov/about-fda/fda-organization/center-tobacco-products
This is the second part of a set of three articles. For more information, check https://medium.com/@kaiyan_medical/part-1-3-the-design-history-file-d681a7945968 with the introduction to DHF.
The device master record (DMR) is the compilation that contains all the information and specifications needed to produce a medical device from scratch to finish. Should include the instructions for all manufacturing processes, drawings, documented specifications, and, packaging requirements. While the device history record makes reference to specific lots, units, or batches of product, the DMR contains specifications for producing an individual device.
The FDA regulations for DMR appear in 21 CFR Part 820.181, under subpart M which handles record-keeping requirements for medical device companies.
When the FDA audits your medical device company, you will be expected to produce a DMR that complies with 21 CFR Part 820.181. Here’s the full text of that part for reference:
Each manufacturer shall maintain device master records (DMR’s). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with 820.40. The DMR for each type of device shall include, or refer to the location of, the following information:
a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
d) Packaging and labeling specifications, including methods and processes used; and
e) Installation, maintenance, and servicing procedures and methods.
The main purpose of the DMR is to centralize a record of the production process in a way that distinguishes it from the design process. A product engineer might design a silicone part for a medical device and include it in the design outputs portion of the design history file, but the DMR would also include specific instructions for manufacturing the part, including what mold to use, equipment specifications and production methods.
The good news is that the FDA requires you to only reference the mandated items, not duplicate them. If you’ve been organized in creating your DHF, you’ll be able to easily reference that location in your DMR.
The difference between the DHF and the DMR is about design vs device. The design history file is focused on capturing the history of the design and ensuring that it was done according to FDA regulation. The device master record is focused on building the device and ensuring that all necessary items are included to build, test, package, and service it.
The food and drug administration(FDA) quality system requirements for all medical device companies are documented in the federal code of regulations, under 21 CFR part 820.
In 1990, the FDA mandated the design history file (DHF) as part of the safe medical devices act. It contains all of the product development documentation pertaining to a finished medical device. The DHF was the last step in the design controls process mandated by the FDA in 21 CFR Part 820.
The FDA’s mandate for quality systems states that each medical device company must establish and maintain a quality system that meets the requirements of its regulations and is appropriate for the medical device they manufacture. Differently classified medical devices may have different requirements under the quality system guidelines. For example, Class I medical devices (with some exceptions) are exempt from the design controls portion of the regulations, but in general, the guidelines must be satisfied to permit the sale of a medical device within the United States.
Medical device companies should consider the quality system regulations as their “key to admission” into the medical devices marketplace.
Subsection j) of 21 CFR part 820 says:
Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.”
DHF is primarily an organizational tool meant to show that the design controls process was properly followed and documented throughout product development while the majority of the medical device compliance regulations enforce the establishment of policies and procedures for enforcing quality standards. Design controls are one of the core processes of the overall quality management system (QMS) mandate, and the presence, completeness, and accuracy of your DHF go a long way towards helping you pass your next FDA audit.
Here are some key interpretations of the DHF guidance that medical device companies should take note of:
Below, we’ve listed the steps of the design controls process and what documents should be included with each step:
This is the last part of a set of three articles. For more information, check https://medium.com/@kaiyan_medical/part-1-3-the-design-history-file-d681a7945968 with the introduction to DHF and https://medium.com/@kaiyan_medical/part-2-3-the-design-master-record-c8348c1e029a for the introduction to DMR.
The establishment of device history records (DHR) is one of the last steps in the compliance process for medical devices. It falls under subpart M of 21 CFR Part 820, which deals with general record-keeping requirements for medical device companies. The FDA mandates that all medical device companies should have the documentation related to manufacturing and tracking according to the information in the device master record.
Manufacturers are subject to this part whether they keep records on paper, or use web-based software. The DHR serves as a production record for medical devices that you manufacture. The entries into this document must include acceptance records for individual units or batches of product, along with product counts, labels, and any unique product identifiers that have been applied.
Most sections of 21 CFR Part 820 refer to establishing overall quality processes that affect your product design and manufacturing, but the DHR is different in that it is applied to each batch of products that you produce.
Each manufacturer shall maintain device history records (DHR’s). Each manufacturer shall establish and maintain procedures to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:
(a) The dates of manufacture;
(b) The quantity manufactured;
© The quantity released for distribution;
(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;
(e) The primary identification label and labeling used for each production unit; and
(f) Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used.
The DHR mandate requires that new batches of products are tested to ensure that they meet the product specifications established in the device master record. The mandate also ensures that batches of products are correctly labeled and assigned identification numbers. This creates traceability throughout your supply chain, enabling you to better identify sources of error in case any non-conformance issues arise with your products.
