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

Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market

By Nick Tippmann on August 19, 2019

Challenges with Pediatric Medical Devices

By Nick Tippmann on August 14, 2019

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

Elevating True Quality with Software as a Medical Device for Early Cancer Detection and Treatment

By Nick Tippmann on August 9, 2019

In the U.S. alone, over 80% of the 5,000 biopsies conducted daily come back either falsely negative,...

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 ...

A Firsthand Account of the Origins and Outcomes of FDA's Case For Quality and MDDAP

By Nick Tippmann on July 26, 2019

Patients, providers, and companies are already experiencing the benefits of FDA’s Case for Quality P...

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.

Eliminating Subjectivity and Guesswork with a Modernized Solution to Detecting Ear Infections

By Nick Tippmann on July 12, 2019

If you or your child have ever experienced ear infections, you know how difficult (and painful) they...

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...

Design History File Ready Ideation: An Innovative Approach to Product Development

By Nick Tippmann on July 3, 2019

As a medical device professional, do you know about Design History File Ready Ideation (DHFRI)?

Looking at the Sunset of FDA's Alternative Summary Reporting Program

By Nick Tippmann on June 26, 2019

The FDA recently decided to discontinue its alternative summary reporting program due to the allegat...

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