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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.
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 international legal regulations and managing directors.
Topic overview & dates
Module 1 details
04/11/2024 Technical documentation according to EU-MDR (hybrid)
25.042024 Risk management - content and requirements of ISO 14971 (hybrid)
05/08/2024 Biocompatibility and biological safety (hybrid)
05/16/2024 Clinical evaluation and clinical trial (hybrid)
06/05/2024 Post-market surveillance and vigilance (hybrid)
06/13/2024 The usability process for medical device manufacturers (online)
06/19/2024 European approval and UDI for medical devices (online)
Module 2 details
06/25/2024 Basics of Regulatory Affairs international (online)
July 9th/10th, 2024 Approval process in the USA (2 days) (hybrid)
09/11/2024 Approval procedure in China and Japan (hybrid)
09/26/2024 Approval procedures in Brazil, Mexico, Canada and Australia (hybrid)
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.
Notice
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 6,750.00 is granted.
You can book the modules individually via the following links:
Regulatory Affairs Manager Module 1
Regulatory Affairs Manager Module 2
Funding Opportunity
KONTAKT:
TuttlingenTuttlingen & Online
