Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums

By Edwin Bills, ASQ Fellow, RAC on April 1, 2019

The 2003 edition of ISO 13485 has now been withdrawn and fully replaced by the 2016 edition.[i] As ...

Abbreviated 510(k): Substantial Equivalence Through Performance Criteria

By Jon Speer on March 17, 2019

A recent draft guidance document was published by FDA detailing the expansion of the Abbreviated 510...

Proactive Quality Systems: FDA Is Prioritizing Them...And You Should Too

By Stephanie Christopher, MA, Program Director, Case for Quality & Science of Patient Input on January 13, 2019

FDA’s traditional compliance requirements establish a uniform quality system framework, but do not e...

FDA Case for Quality: 2018 Comprehensive Review

By Jon Speer on January 1, 2019

FDA Computer System & Software Validation - What You’ve Known For 20+ Years Is Changing

By Jon Speer on December 2, 2018

What you’ve known and believed about computer system validation, software validation, and 21 CFR Par...

Quality vs Compliance Metrics (and what's next for FDA's Case For Quality)

By Nick Tippmann on October 21, 2018

What is the FDA looking to drive forward in its Case for Quality initiative?

Regulatory Tips & Strategies from a Former FDA Reviewer

By Nick Tippmann on October 10, 2018

What are some recent trends and observations in the medical device industry regarding regulatory aff...

FDA Aligning to ISO 13485:2016 (and Why It Matters)

By Jon Speer on October 7, 2018

Earlier this year, the FDA announced their intentions to change the US’s current medical device regu...

What You Need to Know About The FDA CDRH Experiential Learning Program

By Nick Tippmann on September 26, 2018

FDA has a new program called, The Experiential Learning Program, which involves CDRH going to medica...

Latest Updates on CDRH Standards Program and IEC 60601

By Nick Tippmann on September 19, 2018

Medical device standards seem to change and evolve all the time. Is it impossible to keep up with th...

Why the FDA Case for Quality Matters

By Jon Speer on September 13, 2018

When I first learned about the FDA’s Case for Quality initiative, I immediately wanted to learn more...

21 CFR Part 11: A Complete Guide

By Jon Speer on September 10, 2018

Medical device companies that wish to sell their devices in the US and EU must implement a quality m...

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