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Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device? - Featured Image

Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

FDA recently announced its new Safer Technologies Program (STeP), which intends to make medical devi...
Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents - Featured Image

Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

If you haven’t realized it yet, risk management in the medical device industry isn’t going away. How...
Why Design Verification Matters in Medical Device Design and Development - Featured Image

Why Design Verification Matters in Medical Device Design and Development

Design verification can be a difficult stage for medical device companies to carry out effectively. ...
Right-sizing your QMS - Featured Image

Right-sizing your QMS

Is your quality management system (QMS) right-sized to fit with the people, processes and purpose of...
Challenges with Pediatric Medical Devices - Featured Image

Challenges with Pediatric Medical Devices

Challenges continue with the design and development of pediatric medical devices.
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 ...
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...
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’...
How to Make De Novo a Viable Option for your Medical Device - Featured Image

How to Make De Novo a Viable Option for your Medical Device

Is de novo a realistic regulatory pathway? Or, the “kiss of death” for your product? No, to de novo?...
Grasping the Impact of Artificial Intelligence and Machine Learning on Medical Devices - Featured Image

Grasping the Impact of Artificial Intelligence and Machine Learning on Medical Devices

It seems like every time you turn on the TV, there’s commercials, movies, and shows that highlight t...
Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway - Featured Image

Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway

FDA recently released a new guidance document titled, Safety and Performance Based Pathway, which pe...
Nonbinding Feedback is a New Guidance You Should Know About - Featured Image

Nonbinding Feedback is a New Guidance You Should Know About

FDA has been busy working on guidance documents, including Nonbinding Feedback After Certain FDA Ins...

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