content
With the MDR, the contents of the technical documentation are precisely defined, but many questions still arise in practice. When is what content created and how is the content linked to the development and other processes related to 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 have to be involved when creating the technical documentation, who is responsible for which documents?
In the seminar, these and other questions can be clarified in dialogue.
topic overview
- Overview of the requirements for technical documentation specified in Annex II of the EU-MDR
- Possible structure and management of the 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 Annexes III and XIV of the EU-MDR
target group
This seminar is specially designed for employees who create or maintain technical documentation.
previous knowledge
Prior knowledge of the content of the technical documentation is recommended.
KONTAKT:
Online
