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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...
Qualifying Your Suppliers Using a Risk-based Approach - Featured Image

Qualifying Your Suppliers Using a Risk-based Approach

By Jon Speer on May 19, 2019
This notion of risk-based processes within quality systems is something that has become part of our ...
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 Write Effective SOPs for Medical Devices - Featured Image

How to Write Effective SOPs for Medical Devices

By Jon Speer on May 12, 2019
Writing and enforcing standard operating procedures (SOPs) for medical devices is required by FDA, I...
Advancing MRI Technology As We Know It Today - Featured Image

Advancing MRI Technology As We Know It Today

By Nick Tippmann on May 10, 2019
The field of radiology is constantly changing and evolving overtime. One MedTech innovator who's lea...
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?...
8 Questions About the European MDR Answered - Featured Image

8 Questions About the European MDR Answered

By Jon Speer on April 30, 2019
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production...
How a Shift in Mindset Resulted in a Higher Quality IQ for this Industry Veteran - Featured Image

How a Shift in Mindset Resulted in a Higher Quality IQ for this Industry Veteran

By Nick Tippmann on April 26, 2019
Within the medical device industry, there’s a right way and a wrong way to address quality and compl...
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!
Top 50 Medical Device Product Design and Development Companies - Featured Image

Top 50 Medical Device Product Design and Development Companies

By Nick Tippmann on April 21, 2019
Medical device companies have to overcome many significant challenges when bringing a new product to...
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...
De Novo Pathway: Explaining the Process for Medical Device Companies - Featured Image

De Novo Pathway: Explaining the Process for Medical Device Companies

By Jon Speer on April 14, 2019
The De Novo pathway has been around for more than two decades, but it is still one of the least used...

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