I saw this a couple of months ago but neglected to post. Underwriters Laboratories (UL) has started offering ISO 14971 registration services. Read about it here.
(ISO 14971 is the harmonized, medical device risk management standard)
Update: I just read this article from MD&DI. The author predicts that medical device companies may be audited against ISO 14971. The recent news from UL also seems to predict (or force) 14971 compliance too.Â
Is this really a surprise? Regulatory agencies across the world have emphasized the importance of risk management for many years now. ISO 14971 is the state of the art risk management standard for the medical device industry.Â