Content
Risk management and clinical assessment do not end with the declaration of conformity and market launch of a medical device, but are ongoing processes throughout its lifespan that must incorporate experiences from market feedback and the current scientific and technical status. Appropriate measures for post-market surveillance (PMS) must be planned and vigilance and reporting obligations must be fulfilled. The seminar conveys the theoretical foundations for PMS and vigilance and presents tried-and-tested procedures for practical implementation from planning to taking the necessary measures.
Topic overview
- Legal and normative basis for PMS
- Post-market surveillance
- Post-market clinical follow-up
- Assessment taking risk management into account
- Reporting requirements/vigilance
- Measures and recalls
- documentation
target group
Medical device manufacturers, safety officers, QM managers, regulatory affairs, product managers and those responsible for clinical assessments.
Prior knowledge
Previous knowledge of quality management is recommended, but not mandatory.
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
