Medical Device Design Control

In my career, I’ve often heard the phrase: “don’t tell me; show me”. This phrase captures the essence of Design Control. Design Controls are objective, documented evidence to demonstrate a medical device is safe and effective for its intended use. The elements of Design Control include the following (terminology is specific to FDA’s CFR 820.30):

  • Design & Development Planning
  • Design Inputs
  • Design Outputs
  • Design Reviews
  • Design Verification
  • Design Validation
  • Design Transfer
  • Design Changes
  • Design History File

Design Controls are deliverables to a product development process. In the U.S., Design Controls are required (a.k.a. “the law”) for all class II and class III medical devices and even for a few class I medical devices. Design Control requirements are defined by CFR 820.30 (FDA) and ISO 13485 (specific quality system standard for medical devices). The good news is that FDA regulations and ISO requirements are very similar regarding Design Control. The differences primarily relate to terminology and semantics.

The topic of Design Control is substantial and too broad to cover with this post alone. Future posts will dissect each Design Control element in detail. In the meantime, I would like to share a few sources I find extremely useful on the topic:

Over the years, I have attended several training courses and seminars on the topic of Design Control. I highly recommend attending at least one of these courses. FDA is typically involved and attendees come from many types of experiences and device companies. I used these forums as a sounding board for my Design Control questions and issues. Here are some of the courses to consider:

The topic of Design Control is an area of expertise for Creo Quality. Creo understands how to implement Design Control procedures, forms, and templates within a product development process. If you have questions about Design Controls, contact Jon Speer at jspeer@creoquality.com.

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