Events

Basic course: Technical documentation for medical devices & IVD according to MDR / IVDR

Thursday 20 October
Online meeting

Technical documentation is the basic requirement for product approval as a medical device or in-vitro diagnostics. This seminar explains step-by-step how the technical documentation should be structured so that all the requirements of the new EU regulations (MDR / IVDR) are met.

Audience/Requirements
This basic course is also suitable for participants without previous knowledge or with little previous knowledge. For industry newcomers and start-ups, this course offers an ideal introduction to the legal framework for the approval of medical devices and in-vitro diagnostics.

Trainer
DI Martin Schmid, Managing Director & Senior Consultant en.co.tec Schmid KG
Information about ours trainers

Registration is via en.co.tec. Please follow the registration button. 

Online
only
Basic course: Technical documentation for medical devices & IVD according to MDR / IVDR
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This seminar is a cooperation between en.co.tec  and Human.technology Styria. Registration is via en.co.tec.

440 euros Participation fee for HTS members
490 euros Participation fee for non-members
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.

All you need for the ONLINE seminar at en.co.tec is a laptop with a camera and microphone. The 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. 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.

Declaration

With your registration, you confirm the information given above and agree that the data provided will be electronically recorded and processed. Furthermore, you agree to the transmission of further information by e-mail. Unless otherwise communicated, the "General Terms and Conditions for Qualification Workshops" apply. These can be viewed on our homepage. With your registration and participation in this event, you also give us permission to publish pictures and videos that are created during this event. This consent can be revoked at any time in writing.

Contact HTS

Michael Pichler
+43 699 18899 707
michael.pichler@human.technology.at ​

  • Overview of the requirements of the EU regulations (IVDR / MDR)
  • Structure and content of the technical documentation
  • basic requirements
  • Cross-section of the most important harmonized standards
  • Exercise examples and practical tips