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FDA Plans to Modernize 510(k) - Is the Sky Falling? - Featured Image

FDA Plans to Modernize 510(k) - Is the Sky Falling?

Have you heard the news? FDA caused quite a stir when it recently announced transformative changes t...
Understanding the Blurred Lines Between Consumer Tech and MedTech - Featured Image

Understanding the Blurred Lines Between Consumer Tech and MedTech

Did you know that the Apple Watch was recently granted de novo classification requests by the FDA? P...
Understanding The Differences Between Clearance vs Approval vs Granted - Featured Image

Understanding The Differences Between Clearance vs Approval vs Granted

Are you confused by regulatory terminology? Clearance. Approval. Granted.
Streamlining The Device Marketing Authorization Process - Featured Image

Streamlining The Device Marketing Authorization Process

There are a few additional steps to take when it comes to the Medical Device Single Audit Program (M...
The New Special 510(k): What You Need To Know - Featured Image

The New Special 510(k): What You Need To Know

Have you heard the recent buzz about the FDA’s supposed new Special 510(k) Pilot Program? Is it real...
What's New With PMAs - Featured Image

What's New With PMAs

How do you feel about pre-market approval (PMA) for Class III medical devices?
How to Efficiently Raise Funds for Your Medical Device Company - Featured Image

How to Efficiently Raise Funds for Your Medical Device Company

Are you in the midst of raising funds for a device that you are trying to bring to market? It can be...
7 Habits of Highly Effective True Quality Medical Device Professionals - Featured Image

7 Habits of Highly Effective True Quality Medical Device Professionals

What is true quality? How do you achieve it?
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 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...
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...
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...

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