Data shows that more than half of all FDA recalls of medical devices have been caused by packaging and/or labeling errors. What is the best way to survive an FDA recall? Make sure you are compliant not only by fixing the recall issue, but preparing for the future.
Mark Cusworth, PRISYM ID, examines EU Medical Device Regulation and its implications on labeling – and looks ahead to a Christmas future that could become a nightmare unless companies act now – article published in MedTech Innovation
Comprising a full suite of label and barcode printing applications based on the Oracle Database, PRISYM 360 offers integration to your current manufacturing and ERP systems. PRISYM 360 ensures that your business can meet the labeling requirements for serialized and other Life Sciences products now and in the future.
The continual tightening of regulation around the packaging and labeling of medical devices has so far failed to stimulate a transformation of labeling infrastructure and approach among global device manufacturers.
An examination of UDI implementation and lessons for manufacturers of Class II device. Almost two and a half years after the FDA issued its final rule on a Unique Device Identification system, the clock is ticking relentlessly towards the next critical deadline in the timetable for its compulsory introduction