News ItemNMBio Program on Medical Device Regulation Covers It All

April 18, 2012 – 

In the recent past there was a presentation on the CBS Program “60 Minutes” highlighting the issues surrounding medical device regulation by the FDA. The program mentioned the dynamic tension between patients – who want the newest latest devices at the least cost –and government regulators that are trying to assure produce safety. Medical device companies are caught in the middle.

The April NMBio meeting provided valuable insight into regulations governing medical devices. There was a presentation titled FDA Regulation for Medical Devices – Arvelo, by David Arvelo of the FDA that discussed the classification levels for devices and the requirements for each. He also gave a list of helpful resources for those who wanted to pursue the topic further.

Emmanual Grimaud of Perfea Innovation presented information on medical device regulation in the European Union. His presentation,NMBIO_Medical-Devices-EU, outlined the history of EU regulation, categories that apply to medical devices and what the future may hold in this area.

There was also a presentation from an entrepreneur in the trenches, highlighting some of his experiences with the process. Ries Robinson of Inlight Solutions shared his successes (and a few stumbles) with the NMBio audience.

We have provided copies of the powerpoint presentations on regulation in case you missed this great event!

 

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