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...."