Basic course: Requirements & processes for the development of medical devices & IVDs

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Calendar
When:
2. October 2025 @ 09:52 – 10:52
2025-10-02T09:52:00+02:00
2025-10-02T10:52:00+02:00
FH & Universitäten Gesundheitswesen IVD Medizintechnik Produktentwicklung Regulatory Affairs

This basic course gives you an insight into regulatory requirements and processes for the successful development of medical devices and in-vitro diagnostics. What elements must be included in development projects to ensure that time and cost constraints are met and regulatory requirements are taken into account from the outset?

Participants

This basic course is also suitable for participants with little or no previous knowledge. However, you will need experience with (medical) product development to take part in this seminar.

The seminar contents

Regulatory requirements

  • EU regulations for medical devices and IVDs
  • 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 resources and websites?
  • Do’s and don’ts – unwritten laws
  • Field reports: usability, process validation

This seminar / basic course is part of our online course: Regulatory Specialist for Medical Devices and IVD.

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 certificate 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