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What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers? - Featured Image

What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?

By Nick Tippmann on December 18, 2019
FDA announced the anticipated 2020 launch of a new pilot program known as the Accreditation Scheme f...
Why Supplier Quality Management Is So Important - Featured Image

Why Supplier Quality Management Is So Important

By Nick Tippmann on November 27, 2019
Effectively managing suppliers, vendors, consultants, and other third party entities that provide pr...
FDA is Expanding its Case for Quality Program... Should Your Company Participate? - Featured Image

FDA is Expanding its Case for Quality Program... Should Your Company Participate?

By Nick Tippmann on November 20, 2019
Depending on the level of quality and compliance, medical devices can impact patients’ lives for bet...
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?

By Nick Tippmann on October 16, 2019
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

By Nick Tippmann on October 2, 2019
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

By Nick Tippmann on September 11, 2019
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

By Nick Tippmann on August 21, 2019
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

By Nick Tippmann on August 14, 2019
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

By Nick Tippmann on July 31, 2019
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

By Nick Tippmann on June 26, 2019
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?

By Nick Tippmann on June 12, 2019
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

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?...

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