Posts Tagged ‘Notified Bodies’
BSI adds to Fast Track service offering
BSI has added a new accelerated programme for device manufacturers (CE-Dedicated Fast Track) looking to bring their product to market quickly.
CE-Dedicated FastTrack offers reviews within 45 working days or less and does this by dedicating a reviewer to the project and by performing the review off-site. This is the 4th such initiative BSI have introduced in the last couple of years and in a market where speed to market is key it will prove attractive with device manufacturers although it should be noted that such a service comes at a premium cost.
European Notified Bodies look to strengthen system
Read an interesting article lately that associations representing the majority of European Notified Bodies are working hard to finalise a paper outlining how they plan to strengthen their oversight of medical device manufacturers. This would appear to be in response to the European Commission’s proposed recast of the medical device directives but is the move too late, will it go far enough and how will it work given the diversity of the notified bodies? An issue we’ll definitely be keeping an eye on.
