Medical Device Quality, Regulatory and Product Development Blog

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...

Questions to Ask Before Hiring Your QA/RA Consultant

By Nick Tippmann on October 3, 2018

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

By Jon Speer on September 30, 2018

Would you describe your company as quality focused?

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...

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

By Jon Speer on September 23, 2018

In today’s highly connected world, medical devices often include state-of-the-art software, or, the ...

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...

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

By Jon Speer on September 16, 2018

The long-term success of medical device companies depends on the strength of their foundation. Good ...

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...

15 Habits of Highly Effective Regulatory Professionals

By Nick Tippmann on September 12, 2018

Quality and regulatory professionals in the medical device industry have to deal with a lot. In this...

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...

Greenlight Guru Announces Advanced Document Management

By Nick Tippmann on September 5, 2018

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

How to Embrace Risk for Safer Devices