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Risk Analysis

In the Medical Devices field the Risk Analysis is conducted in accordance with the requirements of ISO 14971 “Medical devices - Application of risk management to medical devices”.

This standard is the basis for dealing with the assessment of compliance with the mandatory requirements set by the European and national legislation in the field of medical devices, of In vitro diagnostic medical devices (IVD), and of active implantable devices (Directives 93/42/EEC, 90/385/EEC and 98/79/EC and subsequent amendments and supplements). The Risk Analysis should cover all stages of the life cycle of a device, from design to information of production and post-production.
Here you can see the portal of the Italian Ministry of Health, where you can find information, updates, regulatory references and utility tools.

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