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According to Art. 15 of the EU-MDR, a person responsible for regulatory compliance (PRRC) is required for every medical technology company. The responsible person plays a key role in this. Depending on the size of the company, several responsible persons can be appointed. As obligations increase, so do additional liability risks. These aspects will be explained in the seminar. In addition, recommendations are given on how the company organization can be structured in order to be able to control the liability risks as well as possible.
topic overview
- Tasks and duties of the person responsible according to Art. 15 EU-MDR
- Legal regulations: Required qualification, obligation to notify, etc.
- Differences between responsible person and safety officer according to previous law
- Differences between responsible person and medical device advisor
- Liability of the person responsible: civil law and criminal law risks
- Division of tasks with several responsible persons
- Consequences for the company organization
target group
Managing directors and board members, executives and employees of manufacturers, dealers and importers of medical devices and medical technology retailers.
previous knowledge
Not mandatory.
KONTAKT:
Online
