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Is Your Medical Device Company CAPA Happy? - Featured Image

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 - Featured Image

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 - Featured Image

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 ...
EU MDR: Not All Doom and Gloom - Featured Image

EU MDR: Not All Doom and Gloom

By Nick Tippmann on May 22, 2019
Feeling gloom, doom, concern, and fear about the new European Union Medical Device Regulation (EU MD...
Biocompatibility Nuances and its Impact on Medical Devices - Featured Image

Biocompatibility Nuances and its Impact on Medical Devices

By Nick Tippmann on May 15, 2019
Biocompatibility can be challenging and frustrating when developing a medical device. Why do you hav...
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

By Nick Tippmann on May 9, 2019
Is de novo a realistic regulatory pathway? Or, the “kiss of death” for your product? No, to de novo?...
The 100th Episode: A Few of My Favorite Moments - Featured Image

The 100th Episode: A Few of My Favorite Moments

By Nick Tippmann on April 25, 2019
Drumroll, please. It’s time to celebrate the 100th episode of the Global Medical Device Podcast!
Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm - Featured Image

Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm

By Nick Tippmann on April 19, 2019
Do you love quality and regulatory and keeping up with all things related to the medical device indu...
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

By Nick Tippmann on April 11, 2019
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

By Nick Tippmann on March 27, 2019
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

By Nick Tippmann on March 8, 2019
FDA has been busy working on guidance documents, including Nonbinding Feedback After Certain FDA Ins...
How and When to Consider Human Factors - Featured Image

How and When to Consider Human Factors

By Nick Tippmann on February 28, 2019
When should you begin to consider human factors with your medical device design and development effo...

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