The aim of this training is to provide a fundamental understanding of the regulatory background for medical devices and in vitro diagnostics—specifically tailored to your requirements. Practical exercises and group work will illustrate the theoretical information and thus help you to learn the relevant regulatory framework in a practice-oriented manner.
The seminar contents
You can select the seminar topics and areas of focus in advance with your trainer from the following contents.
- Regulatory Background & EU Regulations MDR / IVDR
- Definition medical device / IVD
- Classification of medical devices / IVD
- Actors and responsibilities
- General safety and performance requirements
- ISO 13485 – Quality management system for medical devices
- Software development (if applicable to you)
- Risk management
- Clinical data
- Conformity assessment procedure
- Placing on the market
- Medical device vigilance and market surveillance
The focus can also be placed on the role of the medical device consultant, who plays a central role as a link between users and manufacturers of medical devices.
Costs
1 day in-house training: € 3,890 (excl. VAT) for max. 10 participants
incl. seminar documents and certificate of attendance, plus travel expenses
your trainer
We will select the trainer best suited to your needs—depending on your desired areas of focus.
Information about our trainers
Book now:
Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491
