target group
Medical device manufacturers, safety officers, QM managers, regulatory affairs, product managers and those responsible for clinical evaluations.
content
Risk management and clinical evaluation do not end with the declaration of conformity and market launch of a medical device, but are continuous processes over its lifetime that must include experiences from market feedback and the current scientific and technical status. Appropriate post-market surveillance (PMS) measures must be planned, and vigilance and reporting requirements must be met. The seminar conveys the theoretical basics for PMS and vigilance and presents tried and tested methods for practical implementation from planning to taking the necessary measures.
topic overview
- Legal and normative bases for PMS
- Post Market Surveillance
- Post-market clinical follow-up
- Assessment taking into account risk management
- Reporting Obligations / Vigilance
- Actions and Recalls
- documentation
previous knowledge
Prior knowledge of quality management is recommended, but not mandatory.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
