Tuttlingen – The responsible person according to Article 15 EU-MDR holds a key position in medical technology companies. The threads of quality management, technical documentation and clinical evaluation come together here - and these topics will be presented in the certificate course starting on January 18th with practical know-how in order to be able to fill the important role well.
The tasks of the responsible person or persons are as diverse as they are to be implemented consistently. Notified bodies and supervisory authorities not only keep an eye on whether the basic requirements according to EU-MDR are met. They also question the reliability, professional qualifications and involvement of the central functionary in the company. All in all, the responsible person must be able to live up to their eponymous responsibility - and the certificate course of MedicalMountains GmbH creates the basis for this. Among other things, the legal requirements are deepened, the testing of medical devices according to the company's QM system and the monitoring after they are placed on the market. What distinguishes a certificate course from attending individual, scattered seminars: The topics are coordinated, they are interlinked, form an overall picture and are finally tested. And above all, the content is based on day-to-day activities in the company - so that the responsible person can hold all the strings not only in theory, but also in practice.
- January 18 + 19, 2022: Responsible person for regulatory provisions according to Art. 15 EU-MDR (2 days)
- 01/20/2022: Quality management for medical devices according to DIN EN ISO 13485:2016
- 03/23/2022: Risk management - Contents and requirements of ISO 14971
- April 26, 2022: Clinical evaluation and clinical testing of medical devices
