Clinical affairs managers deal with all issues relating to the clinical evaluation and testing of medical devices. The goal is to prove that the medical device is safe to use and provides clinical performance. These parameters must be supported by clinical data and monitored and confirmed over the entire product life cycle. The EU MDR specifies the clinical requirements for placing medical devices on the market in terms of safety and clinical performance.

The certificate course enables graduates to move safely in these subject areas and to initiate and accompany the necessary steps in the company.

target group

Employees from the areas of clinical and regulatory affairs, product management, business development, project managers, consultants, service providers for medical devices, authorities.

Topic overview & dates

Module 1 details
The clinical evaluation at a glance and the Clinical Evaluation Plan (CEP)
07/09/2024 Literature research including safety databases
07/18/2024 The Clinical Evaluation Report (CER)
09/10/2024 PMS/PMCF/PSUR
09/25/2024 SSCP – Summary Report on Safety and Clinical Performance

exam and graduation

After each module, the technical knowledge and skills acquired are tested in writing. Please register for the exam via our appointment calendar . After successfully completing both modules, the participants receive a certificate issued by MedicalMountains GmbH.


The modules can be booked individually. If these are completed within 2 years, you will receive a certificate. When booking both modules at once, a special price of EUR 5,690.00 is granted. We recommend attending Module 1 of the "Regulatory Affairs Manager" in advance.

You can book the entire course or module 2 via the following links:

Clinical Affairs Manager

Clinical Affairs Manager Module 2

Funding Opportunity



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