Jon Speer

Jon Speer is the founder and VP of QA/RA at Greenlight Guru, offering quality management software solutions for medical device companies. Speer is an industry veteran with over 20 years of experience, and has helped dozens of devices get to market over his career in a variety of roles including product development, project management, quality and regulatory. He is a thought leader, speaker and regular contributor at numerous leading industry publications. He is also the host of the #1 most downloaded podcast in the industry, The Global Medical Device Podcast.”

From This Author

Compliance

A Tsunami of Regulatory Changes is Coming

Medical device veteran Jon Speer breaks down the latest changes in the medical device regulatory landscape, both in Europe and the U.S.

Fundamentals

A Guide to Medical Device Corrective Action and Preventative Action (CAPA)

Time and time again the one process that nearly always presents the most challenges to medical device companies, regardless of shape and size, is Corrective Action & Preventive Action (CAPA). This article explores those challenges and provides the reader with best practices and ways to improve the CAPA process and approach.

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Jon Speer

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What's New

FDA Issues Pilot Program to Enhance Medical Device Recalls

FCC Issues Final Rules for Program-Originating FM Boosters

Practical Engineering: Odds and Ends – Navigating the Nuances of Compliance Engineering

FDA Issues Guidance on Third-Party Review Program

FCC Proposes Fine for Video Doorbell Manufacturer