June 20, 2018

[FEATURED] Substantial Drop In Certificates Withdrawn By EU Notified Bodies: Why Now?

Data from TEAM-NB, the EU notified body association, shows a big drop in withdrawn certificates from device firms. Does this signal an improvement in the quality of manufacturers’ submissions to notified bodies?

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October 4, 2017

What the FDA Reauthorization Act Means for Pharmaceuticals and Medical Devices

Signing document

On August 18th, President Trump signed the FDA Reauthorization Act (FDARA). Besides reauthorizing user fees for pharmaceuticals and medical devices for five years the law also focuses on many aspects of device regulation. (more…)

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Generis American Medical Device Summit

October 24-25, 2018

The Westin Lombard Yorktown Center
Lombard, IL 60148

 

Schedule a meeting with our President, Laurie and our CEO, Lalitha

Haven’t registered yet? Contact us to get your 65% discount code!