Seminar: General safety and performance requirements for medical devices and IVDs
The general safety and performance requirements of the new EU regulations for medical devices (MDR) and in-vitro diagnostics (IVDR) are the basis for a conformity assessment procedure. Manufacturers 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 IVDR. Using a detailed checklist, the two trainers will show you which harmonized standards must be complied with for your product and how to apply them.
Participants
This seminar is NOT suitable for participants without prior knowledge. You will need basic knowledge of the conformity assessment procedures and the preparation of technical documentation for medical devices and / or IVDs.
The seminar contents
- Overview General Safety and Performance Requirements
- GSPR for medical devices
- GSPR for in-vitro diagnostics
- Overview of the requirements of the relevant standards
- Methodology & checklists
- Exercise examples
Your trainers
- Marie Salin, Managing Director, West Medica Produktions- und Handels-GmbH – experienced regulatory expert for IVD, consultant, trainer and certified internal auditor
- DI Martin Schmid, Managing Director & Senior Consultant, 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 discounts at a glance
Venue: ONLINE
All you need for our ONLINE seminars is a laptop with a camera and microphone. Our eLearning platform works on all operating systems in web browsers (e.g. Firefox, Safari or Chrome). You will receive the seminar documents and the link to the virtual seminar room by email in good time. The seminar will be interactive – similar to a face-to-face seminar: i.e. you can ask your questions to the lecturer, there will be exercises and also the opportunity to exchange ideas with the other participants.
Click here for your online registration!
For questions: office@encotec.at or +43 1 8863491
