V2022

Driving_in_deep_mud

Using Design Controls to Undermine Medical Device Development – Part 2

3 Comments / Design Controls, Medical Device Development, Quality Systems, Regulatory Compliance, V2022

Nobody sets out to write design control procedures that undermine product development but unfortunately that’s the situation I’ve observed at many medical device companies. In this blog post I continue the list of ways that your quality system can undermine your product teams (part 2 of 2)

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Driving_in_deep_mud

Using Design Controls to Undermine Medical Device Development – Part 1

3 Comments / Design Controls, Medical Device Development, Quality Systems, Regulatory Compliance, V2022

Nobody sets out to write design control procedures that undermine product development but unfortunately that’s the situation I’ve observed at many medical device companies. In this blog post I describe some common ways that your quality system can undermine your product teams (part 1 of 2).

Using Design Controls to Undermine Medical Device Development – Part 1 Read More »

What Are Medical Device Design Controls?

Leave a Comment / Medical Device Development, Regulatory Compliance, V2022

Medical device design controls are the regulations that govern the development of medical devices. The FDA established design controls in 1997 because they found that manufacturing controls alone were not sufficient. The FDA recognized that many patient injuries and deaths were the result of medical devices with fundamental design flaws (i.e. no matter how carefully

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