Aaron Joseph

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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).

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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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Newsletter V. 2021 Issue 2

Leave a Comment / News, Newsletters, V2021

September 2021 Newsletter – Digital Health and Medical Device Software Digital Health encompasses a broad range of products leveraging the latest software and communication technologies to improve patient health and increase the efficiency of healthcare systems. Some of the most innovative are software-only products (SaMD) utilizing sophisticated algorithms to analyze health data and aid clinicians

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