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Clinical Evaluation and Post Market Surveillance

November 15, 2017 @ 09:00 - 16:00

Medtech course

How to fulfill the regulations on Clinical Evaluation?

The new guidance and new MDR drive the Clinical Evaluation process. The requirements are much higher and more detailed. The expectations on industry are high.

We will go through the process:

  • How to make a clinical evaluation plan
  • How to make a literature search plan and report – the appraisal of scientific publications plays a big part
  • How to write the Clinical Evaluation Report (CER) – format, content, who writes
  • How to keep the CER up to date

Post market surveillance (PMS) is a life cycle process and strategy. The process covers most of the activities within your company. The new MDR, ISO 13485:2016 and the coming revision of the ISO 14971 will bring this process to a much higher level. The expectations from Authorities and Notified Bodies will be high.

We will go through the process:

  • What are the interfaces to other processes
  • How to make a PMS plan – where are the inputs
  • How to write the report and communication of the results
  • When to update the report