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Armed for the diverse challenges in quality management: the certificate course provides participants with a comprehensive portfolio of knowledge and tools - not only to find out which specifications exist, but also how they can be implemented specifically 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.
target group
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.
Topic overview & dates
Module 3 - Control
09/13/2023 Post-market surveillance and vigilance for medical devices
10/05/2023 Change management: documentation and traceability
10/11/202 3 CAPA: Deviations – corrective and preventive actions
October 25 & 26, 2023 Internal audits in the medical device industry (2 days)
08.11.202 3 Production Process Control
22.11.202 3 Supplier management and supplier audit (Purchasing Control )
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 all 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 after passing all three module examinations. If you book all three modules at once, S
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