Why Getting FDA 510(k) Clearance Alone Is Not Enough


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...."

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Source: http://peddev.org/news/newsitem?nid=73