Content
A person responsible for regulatory compliance (PRRC) is required for every medical technology company according to Article 15 of the EU MDR. The responsible person has a key role to play. Depending on the size of the company, several responsible people can be named. As the obligations increase, there are also additional liability risks. These aspects will be explained in the seminar. Recommendations are also given as to how the company organization can be designed in order to be able to control liability risks as well as possible.
Topic overview
- Tasks and obligations of the responsible person in accordance with Article 15 EU-MDR
- Legal regulations: Required qualifications, obligation to report, etc.
- Differences between responsible person and security officer under previous law
- Differences between responsible person and medical device consultant
- Liability of the person responsible: civil and criminal risks
- Division of tasks among several responsible persons
- Consequences for the company organization
target group
Managing directors and board members, executives and employees of manufacturers, traders and importers of medical devices as well as medical technology retailers.
Prior knowledge
Not required.
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
Online
