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. Our eLearning platform 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
Regulatory requirements
- EU regulations for medical devices and IVD
- Global: The GHTF Regulatory Model
- USA: FDA - QSR: Design Controls
Processes for medical device development
- Project management
- Quality assurance in development
- Sub-processes for the development process
- from requirements management to design transfer
- Supporting development processes
- Where can I find support, useful sources and websites?
- Do's and don'ts – unwritten rules
- Field reports: usability, process validation
