Content
The legal situation for medical devices does not only include requirements for the products. Responsibilities for the organization of the manufacturing company are also regulated. The medical device consultant in accordance with the Medical Devices EU Adaptation Act (MPEUAnpG) is responsible for fulfilling the obligations within the framework of post-market monitoring and for advising/distributing the products.
These market monitoring obligations include, among other things, tracking the use of the products. Any damage that has occurred to patients, users and third parties, as well as any deviations from the intended use, must be reported to the safety officer or the person responsible. Even trends or observations about comparable competitor products and alternative methods may have to be fed into your own internal reporting chain. All of this is of course particularly interesting if you are only active on the market as a trading company or distributor. In the one-day seminar, the requirements for medical device consultants as well as their tasks and duties are discussed. Practical examples illustrate the topic.
Topic overview
- Introduction to the Medical Devices EU Adaptation Act and the EU MDR
- Classification of products and the consequences thereof
- Safety requirements by considering the product in a therapeutic environment
- Instructions for use, labeling and risk management
- Medical device consultant: tasks and communication requirements
- What is required to be reported?
- Reporting deadlines
target group
Managing Directors, those responsible for placing on the market, safety officers, responsible persons, sales managers, sales employees and medical device consultants.
Prior knowledge
Not required.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
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:
TuttlingenTuttlingen & Online
