on 19 July 2013 | By Ryan Kasun
The latest mobile medical application news on the industry's collective mind is the issuance of an "It has come to our attention..." letter sent to Biosense Technologies in India, essentially questioning why Biosense has not obtained 510(k) clearance for their uChek mobile...
Read Moreon 20 March 2013 | By Ryan Kasun
It seems that for one reason or another supplier controls are a requirement that slips through the cracks of even some of the largest medical device organizations. Those of us in the medical device field should know better since 21 CFR Part 820 clearly includes requirements that...
Read Moreon 15 March 2013 | By Ryan Kasun
They’re just as frightening as Lions and Tigers and Bears, but how much do you know about them? Are they in your medical devices?
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