content
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 must be implemented in a variety of ways and consistently. Notified bodies and supervisory authorities have the task of questioning the qualifications, 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
09/12/2024 Responsible person for regulatory provisions according to Art. 15 EU-MDR (hybrid)
09/24/2024 Quality management according to DIN EN ISO 13485 (hybrid)
10/01/2024 Technical documentation according to EU-MDR (hybrid)
10/15/2024 Risk management - Contents and requirements of ISO 14971 (hybrid)
11/21/2024 Clinical evaluation and clinical trial (hybrid)
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 participants receive a certificate issued by MedicalMountains GmbH.
Funding Opportunity
ESF funding is possible. More information can be found here .
early booking discount
If you register up to 4 weeks before the start of the course, you will receive an early bird discount of 10 percent.
KONTAKT:
TuttlingenTuttlingen & Online
