costs and registration
This seminar takes place in cooperation with Human.technology Styria. Registration is via en.co.tec. Participation fee for HTS members: EUR 440 (excl. VAT)
didactics and methods
The didactic concept follows the principles of adult education. Learning takes place using application-oriented case studies. It is supported by keynote speeches, practical exercises, group work and discussions. Common methods are used by working with Power Point presentations, flip charts, pin boards, etc. Methods and tools for practical implementation are taught.
Certificate of Participation
Before the start of the course, the participants will be informed about what must be achieved in order to obtain a certificate and how the learning outcomes will be checked (active participation, practical exercises, group work, discussion rounds, test). The participants have to fill out a feedback form with questions about the workshop.
What else should you know?
All you need for our ONLINE seminars is a laptop with a camera and microphone. The eLearning platform from en.co.tec works on all operating systems in the web browser (e.g. Firefox, Safari or Chrome). You will receive the seminar documents and the link to the virtual seminar room in good time by email.
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The seminar will be designed interactively - similar to a face-to-face seminar: ie you can ask your questions to the lecturer, there will be practice examples and also the opportunity to exchange ideas with the other participants.
Contact HTS
Michael Pichler
+43 699 18899 707
michael.pichler@human.technology.at
Seminar content
The general safety and performance requirements of the new EU regulation for medical devices (MDR) are the basis for a conformity assessment procedure. Manufacturers of medical devices primarily use harmonized standards to demonstrate compliance with these requirements. This can be worked out efficiently using checklists with the relevant standards.
- Overview of General Safety and Performance Requirements
- Focus: GSPR for active medical devices including software
- Methodology & Checklists
- practice example
- EN 62304 requirements at a glance
- Overview of the requirements of the EN 60601 series of standards
