ISO 14971:2012 for Medical Devices
ISO 14971 is an ISO standard for the application of risk management to medical devices. In 2012, a European harmonized version of this standard was adopted by CEN as EN ISO 14971:2012. It became effective on July 31, 2012. EN ISO 14971:2012 applies only to manufacturers with devices intended for the European market.
The abstract that describes ISO 14971 states
"ISO 14971 is a key standard specifying a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this standard are applicable to all stages of the life-cycle of a medical device."
ISO 14971 Endorsements
Regulatory bodies such as U.S. FDA, Health Canada, EU Competent Authority, Australia TGA, and Japan MHLW require that Risk Management processes must be defined and Risk Management documentation for products must be maintained.
All the above agencies endorse ISO 14971 Medical devices -- Application of Risk Management to Medical Devices.
ISO 14971 References
Some of the key medical device industry standards requiring risk management such as IEC 60601, IEC 62366, ISO 10993, ISO 13485 make references to ISO 14971.
This webinar will benefit medical device companies planning to have a CE mark under the European Union Directive 93/42/EEC. We will discuss what is new in ISO 14971:2012 and help you avoid delays in obtaining or maintaining your CE mark for compliance to the Medical device Directive, EU Directive 93/42/EEC on Medical Devices.
