The world of medical device innovation is exciting, but ensuring the safety and effectiveness of your creations is paramount. Quality does not bend to market forces like automobiles or other consumer goods. In the realm of medical devices quality is systemic, mandatory, codified and highly regulated because lives are literally at stake. It considers a device’s complexity, but it never, ever exempts it from safety standards and good manufacturing practices.


Understanding the Essence of GMP
At its core, Good Manufacturing Practices (GMP) is a set of regulations enforced by agencies like the U.S. Food and Drug Administration mandating minimum requirements for manufacturing, processing, and packaging medical devices. The ultimate goal? To ensure consistent quality and minimize the risk of patient harm.


From our esteemed colleagues at Greenlight Guru, In the United States, the Food and Drug Administration “establishes regulations that govern the sale of food, drugs, biologics and medical devices. FDA requires that manufacturers in these industries establish and maintain quality systems to ensure that their products meet the usability and safety needs of their customers. Quality systems for products that are governed by the FDA are based on Good Manufacturing Practices or GMPs.


“The GMP compliance requirements for medical devices are outlined in the Code of Federal Regulations (CFR), most prominently in the FDA Quality System Regulations of 21 CFR Part 820. This part establishes the requirement for quality systems in medical device companies, mandating quality procedures such as design controls, CAPA process, quality assurance and quality control activities, document controls and more.


“The GMP requirements also include other portions of the CFR. 21 CFR Part 812 deals with investigational device exemptions, allowing devices to be shipped lawfully for the purpose of clinical investigations when they would otherwise be required to comply with a performance standard or to have premarket approval. 21 CFR Part 808 addresses exemptions from Federal regulation of state and local medical device requirements.”

Beyond the topline and legalese, here are a few key GMP principles to appreciate.

Quality Throughout: GMP emphasizes control over every aspect of the manufacturing process from the raw materials from which the device or product is made all the way through to packaging and labeling including documentation throughout. Where did it come from, and how do you know it’s safe? THAT is what regulators want to know. About everything from raw materials, to designs and design history files to verification and validation testing and all points both in between and beyond all the way to the bedside or operating room.

If, for example, a supplier provides the specified material for a component, but not the proper grade of that material, GMP compliance could assist in ensuring that change gets flagged prior to the material being used in production, potentially preventing adverse downstream effects.

Risk-Based Approach: The level of control required by GMP varies depending on a medical device’s design, materials, componentry and intended use and its risk classification. The burden of quality control depends entirely on what you are making, but the burden is never fully absent. A simple bandage (Class I) will have less stringent, yet non-negotiable, controls compared to a life-sustaining implanted device (Class III). But that same simple bandage requires sterilization, a burden that a pulse oximeter or large piece of equipment or hardware may not despite being a much more complex device in terms of design and componentry. It’s all about the device itself, its complexity, its claims, its proximity to the patient and the potential it holds to impact or sustain life.


The shrinking distinction between ISO 13485 vs. 21CFR820: ISO 13485 is a specific quality management standard designed for medical devices. It builds upon the foundation of ISO 9001 (a general quality management standard) by adding specific requirements for medical devices. While there’s some overlap if an organization ISO 9001, 13485 delves deeper into areas like risk management and regulatory requirements specific to medical devices.


On January 31st, 2024, the U.S. FDA adopted a new final rule amends “the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world.


“The FDA has determined that the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of the QS regulation [and thus GMP], providing a similar level of assurance in a firm’s quality management system and ability to consistently manufacture devices that are safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).”


You can read more about the news and its implications here.


Ultimately, the Burden of Risk and Responsibility Lies with the Manufacturer of Record: The “manufacturer of record” is the entity regulatory authorities consider to be the product’s manufacturer. The manufacturer of record is beholden to the federal codes applicable to their product’s classifications and subject to both audits by regulators and litigation in the case of adverse events from product failures, recalls or improper use in some cases.


If there’s a recall, adherence to GMP and the CFR is instrumental in pinpointing the source of the problem and remedying it.


Manufacturers of record will have their names on the packages and labeling for their devices. Johnson and Johnson in the case of the immensely popular Band-Aid brand of bandages, Jackson Medical in the case of the newly approved GloShield or Vesalio for the Neva thrombectomy device designed and developed to treat acute ischemic stroke caused by large vessel occlusions.


The manufacturer of record is ultimately responsible for the safety and quality of the device, its components, and sterilization and / or packaging suppliers or contractors. The manufacturer of record must defend the selection and product of a component supplier. The burden of that defense abates somewhat if a supplier has current ISO 13485 certification, which necessitates an annual independent audit for the organization to carry or claim it.


Independent verification is crucial for demonstrating compliance with GMP. Audits are recommended to be conducted by a third-party organization to provide an objective assessment. Additionally, robust documentation is essential. GMP requires detailed records of the manufacturing process, ranging from raw material testing to robust design history files, product testing and production procedures to name a few.


Addressing Common Misconceptions about GMP

“GMP is too costly to invest in this early in the process.”

“Our device isn’t complex or an implantable, so we don’t need to worry about GMP right now.”

These are two of the most common misperceptions about quality systems and GMP we hear from relatively novice medical device innovators time and time again. We’ll address them briefly here.


  • Costly Burden? Implementing GMP and effective quality management systems might seem expensive upfront, but it’s an investment in quality and safety at all points. Those points build in significance, risk and requirement over time. They also benefit exponentially and sequentially from every early investment in quality systems throughout a medical device’s commercialization journey. Think of the potential costs associated with a product recall due to quality issues. GMP helps prevent such events, saving money in the long run.

  • Only for High-Risk Devices? Even seemingly simple devices like bandages need to comply with GMP standards. This ensures they are sterile and function as intended. The important thing to know is that GMP is mandatory regardless of risk or classification. The weight of that mandatory burden depends on the device itself, its design, use and classification. All of those considerations should be made well in advance of any small batch manufacturing for any verification or validation testing to avoid costly ‘reversals in course’ or other avoidable expenditures.

Getting Started with GMP

The journey towards GMP compliance for a new medical device, however ‘simplistic,’ might seem daunting, but resources are available to help you navigate the process. The FDA website offers a wealth of information on GMP regulations for medical devices. And GCMI is here for you every step of the way in your pathway from the back of the napkin to the bench to the bedside to help you understand the why, how and when on GMP for the most efficient pathway. By embracing GMP from the very beginning of your medical device innovation journey, you lay the foundation for success, efficiency in pathway and expenditure and safeguard all concerned. Remember, GMP is not just about meeting regulations; it’s about creating safe and effective devices that improve people’s lives.


Get in touch with us. It’s never too early.