General safety and performance requirements for non-active medical devices
The General Safety and Performance Requirements of the new EU Regulation for Medical Devices (MDR) form the basis for a conformity assessment procedure. Manufacturers of medical devices primarily apply harmonized standards to demonstrate compliance with these requirements.
This seminar provides an overview of the General Safety and Performance Requirements according to the MDR and focuses specifically on non-active medical devices (including substance-based medical devices). Using a detailed checklist, the trainer will show you which harmonized standards apply to your product and how to implement them.
The seminar contents
- Overview General Safety and Performance Requirements
- Focus: General Safety and Performance Requirements (GSPR) for Non-Active Medical Devices Including Substance-Based Medical Devices
- Methodology & checklists
- Exercise example
- Overview of ISO 10993 Biocompatibility Requirements
- Overview of the requirements of other relevant standards
Your trainer
DI Gabriele Ettenberger-Bornberg, Long-standing expert in material applications and material testing for pharmaceuticals, medical devices, and hygiene, with 25 years of experience in the development and testing of medical devices at OFI Vienna.
Information about our trainers
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.
Book now:
Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491
