Risk Assessment

ISO 14971:2007 or EN ISO 14971:2012 is an international standard for risk management of medical devices. The US FDA, European authorities, Health Canada, the Australia Therapeutic Goods Administration and other regulators recognize it as the "de facto" standard for risk management. ISO 14971 is an integral part of a quality system and should be incorporated into the life cycle process of medical devices. The purpose of ISO 14971 is to establish, document and maintain a risk management process to:

•   Review the intended use of the medical device.

•   Identify hazards and estimate the probability that harm might occur.

•   Estimate the severity of each hazard and evaluate the associated risks.

•   Control those risks and monitor the effectiveness of the controls put in place.

Risk Assessment Services Provided:

•   Process Failure Mode Effects Analysis (PFMEA)

•   Design Failure Mode Effects Analysis (DFMEA)

•   Development of procedures for handling Risk

•   Controls Plans

•   Action items and deadlines

•   Reduce the risk