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NF EN ISO 14971 - Risk Management Applied to Medical Devices

Picto Training ISO 14971 Risk ManagementConsistency with the Technical File; Content of the EC Declaration of Conformity

Course Objectives

This program is designed to provide participants with a variety of knowledge and skills:

  • Understand the methodology of risk management for medical devices according to standard EN ISO 14971
  • Understand the terms and vocabulary in order to document the process and demonstrate that the implemented method meets the requirements of standard
  • Identify tools that can be used under this approach
  • Understand all the elements needed for the technical documentation to address the requirements of directives 93/42/EEC and 90/385/EEC

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