The Medical Devices Introductory Course 2020

Summary • ISO14971:2019 is state of art standard for Directives and Regulations • Standard is consistent with Regulations • Content Deviations are for Directives – incorporated into Regulations

• Be thorough, consistent and objective • Plan out the activities as early as possible • Involve as many functions as needed • Maintain the risk file as an ever living system

The Organisation for Professionals in Regulatory Affairs

Summary Effective risk management delivers:

 Patient safety  State of the art  Value for money  Patient safety!

The Organisation for Professionals in Regulatory Affairs