Content
With the EU MDR, the contents of the technical documentation are precisely defined, but many questions still arise in practice.
When is which content created and how is the content linked to the development and other processes surrounding the medical device? How detailed does the information in the technical documentation have to be? What is the best solution for the necessary information and documents? Which roles must be involved in the creation of technical documentation, who is responsible for which documents?
These and other questions can be clarified through dialogue in the seminar.
Topic overview
- Overview of the technical documentation requirements listed in Annex II of the EU MDR
- Possible structure and management of technical documentation
- Contents and relationships of the various documents within the technical documentation
- Relation to development projects, regulatory affairs and notified bodies
- Maintenance and systematic monitoring (PMS and PMCF) according to Annex III and XIV of the EU MDR
target group
This seminar is specifically intended for employees who create or maintain technical documentation.
Prior knowledge
Previous knowledge of the content of the technical documentation is recommended.
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
