Basic course: Technical documentation for medical devices & IVD
The technical documentation is the basic requirement for product approval as a medical device or in-vitro diagnostic device. This seminar explains step-by-step how the technical documentation should be structured so that all requirements of the new EU regulations (MDR / IVDR) are met.
Participants
This basic course is also suitable for participants with no previous knowledge. This course offers an ideal introduction to the legal framework for the approval of medical devices and in-vitro diagnostics for industry newcomers and start-ups.
The seminar contents
- Overview of the requirements of the EU regulations (IVDR / MDR)
- Structure and content of the technical documentation
- Definitions and basic requirements
- General requirements according to MDR/IVDR Annex II
- Special requirements MDR Annex II
- Special requirements IVDR Annex II
- Annex VIII: Classification rules for medical devices and IVDs
- Exercise examples on intended use, classification and many practical tips
Your trainer
DI Martin Schmid, Managing Director & Senior Consultant at 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 confirmation 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
