The certificate course is aimed at employees in quality management who are responsible for the implementation of the specific requirements in the development, manufacture and monitoring of medical devices and who want to bring their specialist knowledge up to date, as well as at managing directors or at QM Specialists who want to switch to medical technology from other industries.
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.
Module 3 focuses on the monitoring of manufacturing processes, considering internal and supplier audits as well as post-market surveillance and vigilance.
Topic overview & dates
Module 3 - Control
10/13/2022 Post-market surveillance and vigilance for medical devices
11/10/2022 Change management: documentation and traceability
11/15/2022 CAPA: Deviations - Corrective and Preventive Actions
November 22 & 23, 2022 Internal audits in the medical device industry (2 days)
12/01/2022 Production Process Control
12/08/2022 Supplier management and supplier audit (Purchasing Control )
exam and graduation
After the module, the technical knowledge and skills acquired are tested in writing. Please register for the exam via our appointment calendar.
After passing the exam in all three modules, the participant receives a certificate issued by MedicalMountains GmbH.
The modules can be booked individually. If these are attended within 2 years, you will receive a certificate. If you book all three modules at once, you will receive a special price.
Investment EUR 3,200.00 plus VAT plus EUR 100.00 examination fee
You can use the following links to book additional modules or the entire certificate course:
ESF funding is possible. More information can
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