Outlining the Design Control Process of Medical Devices

In the medical industry, Design Controls facilitate the structural and developmental process of medical devices, particularly Class II and Class III medical devices. They ensure medical devices are safe, functional, and meet end-user requirements when used.

Medical devices carry various levels of risk and thus need to be managed with care. In this article, we’ll show you how to get the stamp of approval from the FDA by outlining the Design Control process in easy-to-follow phases.

Does Your Product Require Device Controls?

Above all else, Design Controls ensure the safety of the medical device you’re developing. Without them, your medical device won’t be approved by the FDA and won’t be safe for use or purchase. 

The FDA separates medical devices into three categories depending on their impact, potential risk, and invasiveness for patients. Class I products usually don’t require Device Controls, but Class II and Class III do.

Class I

Class I medical devices are low-risk products that require general controls, bandages, non-electric wheelchairs, bedpans, and the like. Around 47% of all medical devices fall under this category, of which 95% are exempt from the regulatory process. 

Class II

Class II devices encompass 43% of all medical devices. These products are medium-risk and non-invasive, such as surgical needles, powered wheelchairs, pregnancy testing kits, and x-ray machines.

Class II devices are subject to both general and special controls by the FDA, which include compliance for labeling, performance, clinical testing, and post-market surveillance.

Class III

Class III devices are invasive and high-risk medical devices that are implanted, used to support or sustain life, or present a risk of illness or injury. Only about 10% of products fall under this category. They’re heavily regulated by the FDA and have strict Design Control requirements.

Examples of Class III devices include breast impacts, pacemakers, and high-frequency ventilators.

What Are the Phases of Design Controls?

Design Controls come with nine different phases, including:

  1. User Needs: Defines how the device you’re developing meets the needs of its intended users.
  2. Design and Development Planning: Creates a transparent design and development plan that addresses the requirements of the regulation.
  3. Design Inputs: Describes the exact specifications of the product, including what it is, what it’ll do, and how it’ll perform in action.
  4. Design Outputs: Describes how the product is built, including the materials and components used to physically make the medical device. This may be shown in writing or in the form of diagrams and drawings.
  5. Design Review: Conducts formal design reviews with you and your team and qualified third-party personnel to ensure the product meets the basic requirements.
  6. Design Verification. Tests the product in various methods, environments, and techniques to ensure it’s been developed as intended.
  7. Design Validation: Shows proof that the product works and how it’s meant to meet user needs.
  8. Design Transfer: Also known as design production, this phase details the production process of the medical device.
  9. Design Changes: Describes any and all changes that went through the production of the medical device, from its initial development to its final stages.