Newsletter V. 2023 Issue 1 – Announcing Sunstone Pilot’s Adaptive Design Controls
Announcing Sunstone Pilot’s Adaptive Design Controls- Embracing Change – equipping your product teams to handle these new challenges
Announcing Sunstone Pilot’s Adaptive Design Controls- Embracing Change – equipping your product teams to handle these new challenges
September 2022 Newsletter – Integrating Two Worlds of Product Development
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)
September 2022 Newsletter – Integrating Two Worlds of Product Development
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).
March 2022 Newsletter – Back to Basics with Design Controls. Changes are coming to design control regulations. Advanced design controls
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 …
Wishing you all the best during this Holiday season and a prosperous New Year. Aaron Joseph Streamlined Compliance for Medical Device Development Sunstone Pilot, Inc. sunstonepilot.com
December 2021 Newsletter – Digital Health – Big Updates from FDA
Big news! After 16 years the FDA is changing its guidance on the software documentation needed in regulatory submissions.