C o n te n ts _
The certificate course imparts practice-oriented knowledge about the tasks and duties of the responsible person according to Art. 15 EU-MDR in the areas of quality management, technical documentation, clinical evaluation/clinical testing and post-market monitoring. The tasks of the responsible person(s) are to be implemented in a diverse and consistent manner. Notified bodies and supervisory authorities have the task of questioning the qualification, reliability and the position or involvement of these central functionaries in the company. The content of the course includes, among other things, the legal basis, the testing of medical devices in accordance with the operational QM system and post-market surveillance.
target group
Employees who are allowed to fill the position of responsible person according to the requirements specified in Art. 15 EU-MDR.
Topic overview & dates
April 18 & 19, 2023
Responsible person for regulatory provisions according to Art. 15 EU-MDR (2 days) (online)
05/02/2023 Quality management for medical devices according to DIN EN ISO 13485:2016 (online)
06/27/2023 Risk management - Contents and requirements of ISO 14971 (hybrid)
07/18/2023 Clinical evaluation and clinical testing of medical devices (hybrid)
Test.
exam and graduation
After the course, the technical knowledge and skills acquired are tested in writing. Please register for the exam via our appointment calendar . After passing the exam, the participant receives a certificate issued by MedicalMountains GmbH.
Notice
The certificate obtained supplements the specialist knowledge of future responsible persons, but does not replace their basic qualifications in accordance with Art. 15 EU-MDR.
Funding Opportunity
ESF funding is possible. More information can be found here .
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
