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

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

When asked whether he hires consultants to help him make investment decisions in the MedTech space, ...
Challenges with Pediatric Medical Devices - Featured Image

Challenges with Pediatric Medical Devices

Challenges continue with the design and development of pediatric medical devices.
When Should You Start a QMS? - Featured Image

When Should You Start a QMS?

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 - Featured Image

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

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 - Featured Image

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

Artificial intelligence (AI) and machine learning (ML) seem to be involved in everything, including ...
Importance of Software Requirements in Product Development - Featured Image

Importance of Software Requirements in Product Development

Software and other requirements are critically important to medical device product development.
4 Facts That May Surprise You About FDA - Featured Image

4 Facts That May Surprise You About FDA

From creating product codes to following regulations, do you ever wonder what goes on inside the U.S...
Looking at the Sunset of FDA's Alternative Summary Reporting Program - Featured Image

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

The FDA recently decided to discontinue its alternative summary reporting program due to the allegat...
Challenges with MedTech Innovation - Featured Image

Challenges with MedTech Innovation

The medical device industry strives to develop high quality and innovative products that will contri...
Is Your Medical Device Company CAPA Happy? - Featured Image

Is Your Medical Device Company CAPA Happy?

The medical device industry could be more proactive than reactive when managing systemic issues. We’...
Greenlight Guru In the Classroom: A University's Real-world Approach - Featured Image

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

Greenlight Guru continues to bridge the gap in biomedical engineering education by helping students ...
EU MDR: Not All Doom and Gloom - Featured Image

EU MDR: Not All Doom and Gloom

Feeling gloom, doom, concern, and fear about the new European Union Medical Device Regulation (EU MD...

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Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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