On Jun 5, 2012 the FDA is officially launching ISO 13485 Voluntary Audit Submissions Pilot Program that will allow ISO 13485 certified companies to submit ISO 13485 audit reports from previous 2 years, copy of current ISO 13485 certificate, FDA … Continued
If you are in the medical device industry, either as an inventor, developer, or manufacturer, and you are planning to market in the US, reviewing FDA warning letters should be part of your weekly if not daily routine. You will … Continued
Recently, I read an FDA report entitled “Understanding Barriers to Medical Device Quality”, which examines the current quality status of medical devices. This informative report compiles the serious adverse events recorded in FDA’s Manufacturer and Used Facility Device Experience (MAUDE) databases, … Continued
On Dec 27, 2011, the FDA released an important new draft guidance entitled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications”. Once issued, this guidance will replace “Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3” from … Continued
These days you can read a lot about the advantages of cloud–based, shared infrastructure. Public virtual server providers are praised for scalable and flexible storage, affordable pay-per-use service or subscriptions, and convenient back up and disaster recovery. Many providers are … Continued