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

What's New With PMAs

By Nick Tippmann on October 31, 2018

How do you feel about pre-market approval (PMA) for Class III medical devices?

Greenlight Guru Announces New Integration with Jira Software

By Nick Tippmann on October 31, 2018

Quality management software platform for medical device companies now integrates with industry-leadi...

How to Efficiently Raise Funds for Your Medical Device Company

By Nick Tippmann on October 24, 2018

Are you in the midst of raising funds for a device that you are trying to bring to market? It can be...

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?

7 Habits of Highly Effective True Quality Medical Device Professionals

By Nick Tippmann on October 17, 2018

What is true quality? How do you achieve it?

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...

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 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...

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...

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