Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
There has been a steady uptick in the number of FDA 483s that cite inadequate supplier controls — from 84 in 2011, to 110 in 2012 and 126 last year. The problem is now one of the top five most common 483 findings for devicemakers. Read More
As the July 22 deadline for complying with new EU requirements on hazardous substances approaches, some manufacturers of medical devices and active implantable medical devices are feeling a financial squeeze. Read More