General safety and performance requirements for active medical devices (incl. medical software & apps)
The general safety and performance requirements of the new EU Medical Device Regulation (MDR) are the basis for a conformity assessment procedure. Manufacturers of medical devices primarily use harmonized standards to demonstrate conformity with these requirements. This can be done efficiently using checklists with the relevant standards.
This seminar provides an overview of the general safety and performance requirements according to MDR and deals specifically with active medical devices (incl. medical software & apps). Using a detailed checklist, the trainer will show you which harmonized standards must be complied with for your product and how to apply them.
The seminar contents
- Überblick General Safety and Performance Requirements
- Focus: GSPR for active medical devices incl. software
- Methodology & checklists
- Exercise example
- Requirements of EN 62304 at a glance
- Requirements of the EN 60601 series of standards at a glance
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 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
