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How to Efficiently Raise Funds for Your Medical Device Company - Featured Image

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) - Featured Image

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 - Featured Image

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?
15 Reasons Why Medical Device Companies Choose Greenlight Guru - Featured Image

15 Reasons Why Medical Device Companies Choose Greenlight Guru

By Jon Speer on October 14, 2018
The medical device industry has been undergoing a major shift for the past 20 years, and now that sh...
Regulatory Tips & Strategies from a Former FDA Reviewer - Featured Image

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) - Featured Image

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 - Featured Image

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 - Featured Image

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 - Featured Image

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)? - Featured Image

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 - Featured Image

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) - Featured Image

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 ...

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