Regulatory Expectations in Medical Device Development 101

Discovering an idea for a medical device design that can change the world is great, but is only the beginning. Without fully understanding the regulatory and planning requirements for the medical device development process, your project is destined for failure, which will be both time-consuming and expensive. Here are some of the key principles you should know about the regulatory requirements to prevent any major shocks along the way.

There are many regulatory requirements in medical device design and development planning - the key requirements are laid out for you in section 7.3.2 of ISO 13485:2016 and FDA 820.32 (c). We’ve broken these documents down down further:

Section 7.3.2:

This focuses on the design and development requirements for quality management systems that can be used in the market. These include things like:

• During design and development planning, the organization shall document:
  1. The design and development stages;
  2. The review(s) needed at each design and development stage;
  3. The verification, validation, and design transfer activities that are appropriate at each design and development stage;
  4. the responsibilities and authorities for design and development;
  5. the methods to ensure traceability of design and development outputs to design and development inputs;
  6. the resources needed, including necessary competence of personnel

FDA 21 CFR part 820.30

This focuses on design controls, something that can only be achieved with proper planning ahead. This means you should be able to block out milestones, anticipate financial and technical challenges, and have a release date in mind for your medical device. 

• Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves.

A key takeaway from this is that the design and development plan should indicate how all required risk management activities related to the risk management plan, file, and report will be incorporated within the product realisation process. Whilst it may seem simple to make a plan - just make a Gantt chart, right? - this is slightly more advanced. Whilst the official documentation does not dictate the need for expected delivery dates, most manufacturers and businesses will require them. 

21 CFR 820.30 and ISO 13485 7.3.2 clearly set out that a design plan must include the definition of all planned project activities performed by different groups, as well as a description of the interactions between any of these groups or activities. This can seem confusing - in short, you must define your core team and their competencies, and comment on how they will interact with each other during the development process. Furthermore, your design plan must comply with the design controls process and each step of the development process should be documented. These official guidelines say that activities and duties should be documented and regularly updated, with no further reference to how, meaning you have a wide scope to proceed with your planning and documentation however you wish. However, at Nectar we can help shape your plan to achieve and sustain superior performance with our cutting-edge software and techniques.

Is it necessary to follow all of these guidelines?

It is a regulatory requirement to follow all of the above procedures if you want your product to gain FDA approval. Whilst this blog outlines the key points from these documents and you can easily read through the documents yourself, it is worth appreciating that it takes years of industry experience to fully comprehend the medical device development process fully. It may seem like a complex, challenging process, but it really doesn’t have to be. Not only is our QMS here at Nectar ISO 13485:2016 certified, but we truly are experts at what we do - we’ve been collaborating with innovative companies for over 30 years and creating medical devices that are life-changing. Don’t just take our word for it, though - have a look at our portfolio and let our success stories speak for themselves.