This course provides comprehensive instruction on the EU MDR. It covers every aspect of the regulation and identifies key topics and changes, including economic operators and new roles associated with EU MDR, standard requirements that must be met by all manufacturers regardless of class, and the pre- and post-market requirements of conformity assessment.
By the end of this course you should be able to:
- Recognize the regulatory background in Europe
- Identify the roles associated with the EU MDR
- Discuss the manufacturing requirements of the EU MDR
- Explain how to comply with pre and post market requirements for conformity assessments.
By completing/passing this course, you will attain the certificate Medical Device Certificate
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