Re: BS EN ISO 14971:2009 What new!
Wow!, it is then time now to buy the new std.
On BSI website I found this detail:
"BS EN ISO 14971 Medical devices. Application of risk management to medical devices has been revised and now contains three additional informative annexes, to ensure conformity with a means of conforming to the Essential Requirements of the EU Directives 93/42/EEC (medical devices), 90/385/EEC (active implantable medical devices) and 98/79/EC (in vitro diagnostic devices)."
and
"BS EN ISO 14971:2009 replaces BS EN ISO 14971:2007, which has been withdrawn"
Thanks for sharing!
Alberto