content
The biological safety of medical devices must be taken into account during both development and manufacture. The corresponding proof is part of the conformity assessment procedure. In this seminar, the content 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 reference to risk management
- Regulatory requirements including EU MDR requirements
- argumentation aids
target group
Employees in development, quality assurance, clinical affairs and regulatory affairs.
previous knowledge
Basics in risk management and in the structure of technical documentation are recommended.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
