M-PED provided connections to resources in regulatory investigation and intellectual property (including patent searches) that were critical to the development of the Charpie Pediatric Intubation System. The Gap Funding Award is helping me turn the conceptual design into a functional prototype in a collaboration with a local medical device firm.
Sourced from MedCity News (www.medcitynews.com)
"During the past several months, I have talked to and worked with dozens and dozens of medical device companies in pursuit of or receipt of a 510(k) clearance letter.
There is an alarming trend happening in the medical device industry right now. And the trend is this.
Many medical device companies are compiling and submitting 510(k)s to FDA for review without establishing a QMS, without documenting Design Controls, and without document Risk Management...."
Read more:
http://medcitynews.com/2015/12/why-getting-510k-clearance-not-enough/
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