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

How to Solve the Medtech Value Equation with Quality Data

By Nick Tippmann on December 4, 2019

Which medical technology, product, or device are you actively focused on bringing to market that wil...

Why Supplier Quality Management Is So Important

By Nick Tippmann on November 27, 2019

Effectively managing suppliers, vendors, consultants, and other third party entities that provide pr...

State of Medical Device Product Development and Quality Management Report 2020

By Jon Speer on November 25, 2019

Greenlight Guru, the only medical device quality management system (MD QMS) software platform, today...

FDA is Expanding its Case for Quality Program... Should Your Company Participate?

By Nick Tippmann on November 20, 2019

Depending on the level of quality and compliance, medical devices can impact patients’ lives for bet...

Preparing for EU MDR

By Nick Tippmann on November 13, 2019

Do you have a regulatory strategy to help your company prepare for the new European Medical Device R...

Tips for Success with IEC 60601 for Electrical Medical Devices

By Wade Schroeder on November 10, 2019

Does your company develop electrical medical devices? The standard IEC 60601 is different from other...

Addressing Top Questions of QA/RA Candidates on Salary, Skill Sets and Job Satisfaction

By Nick Tippmann on November 6, 2019

Quality Assurance and Regulatory Affairs (QA/RA) professionals need to keep their finger on the puls...

The Ultimate Guide to the EU MDR General Safety and Performance Requirements (GSPR)

By James Gianoutsos and Rod Beuzeval on October 20, 2019

Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

By Nick Tippmann on October 16, 2019

FDA recently announced its new Safer Technologies Program (STeP), which intends to make medical devi...

7 Tips to Attract Investors and Raise Funds for your Medical Device

By Jon Speer on October 13, 2019

Is your medical device company in the midst of raising funds or planning to begin the process? There...

5 Do's and Don'ts when Choosing a QMS Solution for your Medical Device Company

By Jon Speer on October 6, 2019

As a medical device manufacturer, your quality management system is the heart of your operations.

Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

By Nick Tippmann on October 2, 2019

If you haven’t realized it yet, risk management in the medical device industry isn’t going away. How...

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