Getting a medical device cleared by the FDA is a challenging process. At Flexan, we’ve developed expertise over several decades of critical experience in ushering medical device components through the FDA submission process. In this article, we are going to share some valuable tips we have learned in this arena after going through the FDA submission process successfully.

FDA clearance for medical devices and components can be intimidating when you’re trying to bring something new or innovative to market. The regulatory agency has conditions and activities which must occur in order for something to end up in the market. Additionally, if you want to reach a global market, then you will need to work through international regulatory agencies.

We will analyze what the FDA regulations are, and what governs their rules for medical devices. We’ll also take a high-level look at the ISO certification at Flexan, which goes above and beyond to help with global regulations. If you have questions, contact Flexan today.

Understanding 21 CFR Part 820 Compliance

The FDA created 21 CFR Part 820 as a set of specific and detailed regulations that govern current proper manufacturing practices for medical devices.

By having a QMS that is complaint to 21 CFR Part 820, a medical device manufacturer should register their establishment with the FDA if it has not already done so. Flexan’s QMS is complaint to 21 CFR Part 820 and is audit ready for any 3rd party or unannounced audits.

21 CFR Part 820 Compliance vs. ISO 13485

When discussing compliance and certifications, often ISO 13485 gets mentioned right along with regulations like 21 CFR Part 820. Before we breakdown what ISO 13485 is and how it compares to 21 CFR Part 820, note that they are both meant to provide regulatory and safety measures for medical devices. One of the key differences is that 21 CFR part 820 is specific to the FDA Quality System Regulations, while ISO 13485 is a set of Quality Requirements geared towards an Internationally Recognized Standard.

Here are some of the key components of ISO 13485:

  1. ISO 13485 is built on the foundation of ISO 9001, but it is focused exclusively on medical devices. They designed it for companies involved in the design, production, installation, and servicing of medical devices and related services. Internal and external parties can also use ISO 13485, such as certification bodies, to help them with their Quality Management System and auditing processes.
  2. What is the purpose of receiving an ISO 13485 certification? First, it is important to know that an ISO 13485 certification is not a requirement of the standard. An organization can reap benefits from implementing strict standards and processes without undergoing an official certification process. The benefit is that a third-party certification demonstrates that device manufacturers have met the requirements of the standard, which is strict enough that it paves the way for meeting regulatory requirements
  3. How often are ISO 13485 standards revised? As the medical devices industry is constantly changing, so too must the standards be revised. The standards are reviewed every five years, which establishes if a revision is required to keep current and relevant for the marketplace. As an example, the ISO 13485:2016 was updated to respond to the latest quality management system practices, changes in technology, updated regulatory requirements, and new medical device expectations. The most recent standard revision placed a greater emphasis on risk management, risk-based decision making, and changes to increased regulatory requirements for organizations.

The Benefits of ISO 13485 Certification

  1. Faster Cycle Times. The QMS requirements for ISO, reduces waste and creates faster cycle times to supply chain and with production.
  2. Less Waste. The ISO standards can improve production and find ways to reduce waste.
  3. Systematic Process Improvement. The ISO standards improve the process by which medical devices and components are made.
  4. Higher Customer Satisfaction. Better quality management, less waste and faster cycle times mean happier partners for CMOs and more satisfied patients at the end of the process.
  5. The Trust Factor. Being ISO 13485 certified communicates to other medical device companies and competent authorities that you have a trustworthy Quality Management System.
  6. Smooths Certification and Approval for Most Regulatory Boards. ISO standards correlate with the world’s competent authorities to allow for faster times to market across the globe.

Flexan’s Quality Management System is complaint to 21 CFR 820 and certified to ISO 13485:2016.

Flexan is a successful contract medical device manufacturer specializing in helping OEM companies bring their products to market quickly and efficiently. We have developed a process of partnering with Medical Device companies to bring their medical devices from concept to market. Our quality standards and decades of experience allow us to not only support our customers build an outstanding medical device but to manufacture in an environment that complies with the 21 CFR 820 Regulations and ISO 13485 Standards.

Flexan’s Quality Management System is also compliant with the new European Union Medical Device Regulation 2017/745. By acting as an Economic Operator, and with the use of a well-orchestrated Quality Agreement, Flexan can help you produce products for the European Market.


If your medical device company could benefit Flexan’s experience in bringing medical devices to market, contact our sales team today.