The newly revised standard, BS EN ISO 14971:2007 medical devices, which is concerned with the application of risk management, is now available from BSI British Standards.
For more information visit www.bsi-global.com/ BSENISO14971.
New standard in risk management for medical devices
BS EN ISO 14971 specifies a process through which the manufacturer can identify the hazards associated with a medical device, estimate and evaluate the risks associated with these hazards, control the risks and monitor the effectiveness of that control.
For more information visit www.bsi-global.com/ BSENISO14971.
