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Regulatory Tips & Strategies from a Former FDA Reviewer - Featured Image

Regulatory Tips & Strategies from a Former FDA Reviewer

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) - Featured Image

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

Earlier this year, the FDA announced their intentions to change the US’s current medical device regu...
Questions to Ask Before Hiring Your QA/RA Consultant - Featured Image

Questions to Ask Before Hiring Your QA/RA Consultant

Do you work with regulatory consultants to implement a quality system or 510(k), or perform other ta...
What it Means to be Focused on Quality vs. Compliance - Featured Image

What it Means to be Focused on Quality vs. Compliance

  Would you describe your company as quality focused?
What You Need to Know About The FDA CDRH Experiential Learning Program - Featured Image

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

FDA has a new program called, The Experiential Learning Program, which involves CDRH going to medica...
What are the Regulatory Expectations for Software as a Medical Device (SaMD)? - Featured Image

What are the Regulatory Expectations for Software as a Medical Device (SaMD)?

  In today’s highly connected world, medical devices often include state-of-the-art software, or, th...
Latest Updates on CDRH Standards Program and IEC 60601 - Featured Image

Latest Updates on CDRH Standards Program and IEC 60601

Medical device standards seem to change and evolve all the time. Is it impossible to keep up with th...
The Importance of Good Document Management (And How To Do It) - Featured Image

The Importance of Good Document Management (And How To Do It)

The long-term success of medical device companies depends on the strength of their foundation. Good ...
Why the FDA Case for Quality Matters - Featured Image

Why the FDA Case for Quality Matters

  When I first learned about the FDA’s Case for Quality initiative, I immediately wanted to learn mo...
15 Habits of Highly Effective Regulatory Professionals - Featured Image

15 Habits of Highly Effective Regulatory Professionals

Quality and regulatory professionals in the medical device industry have to deal with a lot. In this...
21 CFR Part 11: A Complete Guide - Featured Image

21 CFR Part 11: A Complete Guide

Medical device companies that wish to sell their devices in the US and EU must implement a quality m...
Greenlight Guru Announces Advanced Document Management - Featured Image

Greenlight Guru Announces Advanced Document Management

Functionality enhances security while maintaining visibility and transparency in medical device qual...

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