MedicalMountains GmbH

Service Provider

MedicalMountains GmbH Regulatory Affairs Manager Module 1

content

On the one hand, regulatory affairs managers have the task of working closely with authorities and inspection bodies with regard to national and international specifications and regulations, and of creating and applying the relevant documents. On the other hand, they provide intensive support for risk and quality management. The certificate course enables graduates to move confidently in these demanding and multifaceted subject areas and to initiate and accompany the necessary steps in the company. Module 1 deals with aspects of technical documentation, risk management and clinical evaluation, among other things. The content follows a strict practical orientation.

target group

Employees from the areas of regulatory affairs and quality management, those responsible for initial marketing, development managers, employees who are responsible for compliance with national and international legal regulations, and managing directors.

Topic overview & dates

module 1
05/25/202 3 Technical documentation according to EU-MDR - structure and content
06/27/202 3 Risk management - Contents and requirements of ISO 14971
07/04/202 3 Biocompatibility and biological safety of medical devices
07/18/202 3 Clinical evaluation and clinical testing of medical devices
25.07.202 3 The usability process for medical device manufacturers - methods and documentation

Test.

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 participant receives a certificate issued by MedicalMountains GmbH.

a notice
The modules can be booked individually. If these are attended within 2 years, you will receive a certificate. If you book both modules at once, you will receive a special price of EUR 5,490.00.

You can use the following links to book additional modules or the entire certificate course:

Regulatory Affairs Manager Module 2