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

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...

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...

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. ...

Implementing Changes to SaMD under New EU MDR

By Nick Tippmann on September 4, 2019

Classification, qualification, and other changes to Software as a Medical Device (SaMD) under the ne...

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...

Challenges with Pediatric Medical Devices

By Nick Tippmann on August 14, 2019

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

When Should You Start a QMS?

By Nick Tippmann on August 7, 2019

Early-stage startups often wonder when the right time is to consider a quality management system (QM...

How General Wellness Devices Have Opened a Pandora's Box of Confusion

By Nick Tippmann on July 31, 2019

Do you have a Fitbit, Apple Watch, or other general wellness device to track your activity, monitor ...

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...

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