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

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...

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...

Why Design Verification Matters in Medical Device Design and Development

By Nick Tippmann on September 11, 2019

Design verification can be a difficult stage for medical device companies to carry out effectively. ...

Career Tips for QA/RA Professionals in the Medical Device Industry

By Nick Tippmann on August 28, 2019

Medical device quality and regulatory professionals face changes, challenges, requirements, standard...

Right-sizing your QMS

By Nick Tippmann on August 21, 2019

Is your quality management system (QMS) right-sized to fit with the people, processes and purpose of...

How to Evaluate a Company’s Regulatory and Quality ‘Health’ Before Investing

By David Amor on August 18, 2019

When asked whether he hires consultants to help him make investment decisions in the MedTech space, ...

Challenges with Pediatric Medical Devices

By Nick Tippmann on August 14, 2019

Challenges continue with the design and development of pediatric medical devices.

13 Tips For Audit Etiquette Every Medical Device Company Should Know

By Taylor Brown on August 11, 2019

I love audits. Seriously! It is a hybrid experience, like a kindergarten show-and-tell with a classi...

Regulating Artificial Intelligence and Machine Learning-Based Software as a Medical Device

By Nick Tippmann on July 24, 2019

Artificial intelligence (AI) and machine learning (ML) seem to be involved in everything, including ...

Importance of Software Requirements in Product Development

By Nick Tippmann on July 17, 2019

Software and other requirements are critically important to medical device product development.

4 Facts That May Surprise You About FDA

By Nick Tippmann on July 10, 2019

From creating product codes to following regulations, do you ever wonder what goes on inside the U.S...

5 Most Common Mistakes Made When Implementing ISO 14971

By Jon Speer on June 2, 2019

ISO 14971 is a descriptive regulatory standard that provides guidance for how to apply risk manageme...

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