Medical devices. Application of risk management to medical devices Ingestion-build-276583 This could include:

This could include:

Need for a high level of assurance

Risk and safety labelling according to the EU Directives

Show evidence to notified bodies and national authorities by results of a performance evaluation that the IVD MD performs as claimed by the manufacturer

Medical devices. Application of risk management to medical devices Ingestion-build-276583 This could include:BS EN ISO 14971: 2009 Application of risk management to medical devices What is it? BS EN ISO 14971 is the latest international risk management standard for the manufacture of medical devices. It outlines ways to identify, evaluate, control and monitor risks associated with medical device manufacturing, including in vitro diagnostic (IVD) devices. The standard applies to the medical device lifecycle, covering risks to the patient and operator as well