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...

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...

4 Biggest Challenges in Medical Device Manufacturing (and how to overcome them)

By QRA Corp on September 29, 2019

Effective planning is the key to success for any business but to an even greater degree in the medic...

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

By Nick Tippmann on September 25, 2019

Do you know everything there is to know about prototyping, product iteration, and manufacturing to g...

Complete Guide to Bringing a Medical Device to Market

By Tom Rish on September 22, 2019

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.

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