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

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...

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...

Challenges with MedTech Innovation

By Nick Tippmann on June 19, 2019

The medical device industry strives to develop high quality and innovative products that will contri...

Is Your Medical Device Company CAPA Happy?

By Nick Tippmann on June 12, 2019

The medical device industry could be more proactive than reactive when managing systemic issues. We’...

Integrating Human Factors into Design Controls to Improve Patient Outcomes

By Nick Tippmann on June 5, 2019

The relationship between human factors and design controls often creates confusion in the medical de...

Greenlight Guru In the Classroom: A University's Real-world Approach

By Nick Tippmann on May 29, 2019

Greenlight Guru continues to bridge the gap in biomedical engineering education by helping students ...

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