Armed for the diverse challenges in quality management: the certificate course provides the participants with a comprehensive portfolio of knowledge and tools - not only to find out which specifications exist, but also how they can be implemented in the company.

target group

Employees in quality management who are responsible for the implementation of the specific requirements in the development, manufacture and monitoring of medical devices and want to bring their specialist knowledge up to date, as well as managing directors or QM specialists who want to switch to medical technology from other sectors.

Topic overview & dates

Module 1 details
Introduction to quality management (online)
03/21/2024 Quality management according to DIN EN ISO 13485 (hybrid)
04/09/2024 Quality management according to EU-MDR (online)
04/23/2024 Quality management according to 21 CFR 820 QSR (online)
05/07/2024 The QM representative (QMB) (hybrid)
06/04/2024 Digitized management systems (online)

Module 2 details
Design Control (hybrid)
07/03/2024 Validation of processes in the medical device industry (hybrid)
07/16/2024 Cleaning validations within the manufacturing processes (hybrid)
09/25/2024 Production Process Control (hybrid)
02.10.2024 Marketing of medical devices (hybrid)

Module 3 details
10/15/2024 Risk management - Contents and requirements of ISO 14971 (hybrid)
10/23/2024 Change management: documentation and traceability (hybrid)
11/06/2024 CAPA: Deviations/complaints - corrective and preventive measures (hybrid)
November 26th/27th, 2024 Audits in the medical device industry (2 days) (hybrid)
05.12.2024 Supplier management (purchasing control) (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 all 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 all three modules at once, a special price of EUR 9,450.00 is granted.

You can book the modules individually via the following links:

Quality manager medical technology module 1

Quality manager medical technology module 2

Quality manager medical technology module 3

Funding Opportunity

Tuttlingen & Online


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