Content
The biological safety of medical devices must be taken into account in both development and manufacturing. The corresponding evidence is part of the conformity assessment procedure. In this seminar, the contents and requirements of DIN EN ISO 10993 are presented with their relation to risk management and ways for practical implementation are shown.
Topic overview
- Overview of the requirements of DIN EN ISO 10993
- Recommendations for the systematic implementation of the individual steps for demonstrating biological safety with regard to the
- Risk management
- Regulatory requirements including requirements according to EU MDR
- Argumentative aids
target group
Employees from development, quality assurance, clinical affairs and regulatory affairs.
Prior knowledge
Basics in risk management and the structure of technical documentation are 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
