Description
This seminar will be held in German!
Safety is the top priority for medical devices. The systematic analysis and verifiable reduction of risks is therefore a fixed component of legal and normative requirements.
In this seminar, you will learn how to quickly and easily implement the risk management requirements for risk management according to ISO 14971:2019 in your company quickly & easily.
Seminar contents
- Requirements of the EU regulations (MDR / IVDR) and the quality management standards for risk management
- Risk management according to ISO 14971:2019
- Implementation and documentation of risk management with the en.co.tec toolbox:
- Risk management plan
- Risk management acts
- Risk management report
- Exercise example risk management file
Date
21.11.2025 from 9:00 to 16:30
Participants
This basic course is also suitable for participants with little or no prior knowledge. This course offers an ideal introduction to the legal framework for the risk management of medical devices and in-vitro diagnostics for industry newcomers and start-ups.
Your trainer
DI Martin Schmid, Managing Director & Senior Consultant at en.co.tec Schmid KG
Costs
- Early booking (up to 4 weeks before the seminar): Euro 540,- (excl. VAT)
- Standard (from 4 weeks before the seminar): Euro 610,- (excl. VAT)
- incl. seminar documents as PDF and certificate of participation
- All seminar discounts at a glance
