General Safety and Performance Requirements for In Vitro Diagnostics
The General Safety and Performance Requirements of the new EU Regulation for In Vitro Diagnostics (IVDR) form the basis for a conformity assessment procedure. Manufacturers of in vitro diagnostics primarily apply harmonized standards to demonstrate compliance with these requirements. This can be efficiently achieved using checklists with the corresponding standards.
This seminar provides an overview of the General Safety and Performance Requirements according to the IVDR, with a specific focus on in vitro diagnostics. 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: GSPR for In-vitro Diagnostics
- Methodology & checklists
- Exercise example
- Overview of the requirements of the relevant standards
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
Mag. Marie Salin, Managing Director, West Medica Produktions- und Handels-GmbH – experienced regulatory expert for IVD, consultant, trainer, and certified internal auditor
Information about our trainers
Book now:
Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491
