Safety is the top priority for medical devices. Systematic analysis and demonstrable reduction of risks are therefore an integral part of legal and normative requirements. In this in-house training, you will learn with the help of a comprehensive practical example how to implement the requirements of risk management for medical devices & in vitro diagnostics in your company quickly and easily.
Your trainer, DI Martin Schmid, brings more than 20 years of experience as a consultant in the implementation of risk management systems for medical device and in vitro diagnostics manufacturers.
The seminar contents
- Requirements of EU Regulations for Medical Devices and In Vitro Diagnostics
- 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 file
Risk management report - Sample risk management file
Costs
1 day in-house training: Euro 3.790,- (excl. VAT) for max. 10 participants; incl. seminar documents and certificate of attendance, plus travel expenses.
your trainer
DI Martin Schmid, Managing Director & Senior Consultant at en.co.tec
Information about our trainers
Book now:
Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491
