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Events

Crash course: Regulatory requirements for medical devices

Monday, October 23th
13:00 - 17:00 PM
Medical University of Graz

Basics of compliance with legal regulations for medical devices and in-vitro diagnostics in the EU

A course series for researchers, start-up founders and entrepreneurs

Are you a researcher, start-up entrepreneur or entrepreneur and plan to certify medical devices or in-vitro diagnostics in the EU or to participate in such projects?
Take part in our comprehensive course series to gain the necessary knowledge and expertise in regulatory requirements and processes for medical devices and in vitro diagnostics in the EU.
Learn more about the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR) and get practical insights into navigating the certification process.
The series, led by industry experts, includes different modules and provides you with essential knowledge and skills to ensure legal compliance and the successful market entry of your medical devices
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Crash course: Regulatory requirements for medical devices
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MODULES

1. Introduction to the EU MDR & IVDR regulations
2. Practical guidelines of good manufacturing practice
3. Practical introduction to quality management and risk analysis
4. Basics of product validation in the EU
5. Preparation for commercialization in the EU

DETAILS ABOUT THE COURSE SERIES

  • Venue: Medical University of Graz
  • First date: October 23.10.2023rd, 13.00, 17.00:1 p.m. – XNUMX:XNUMX p.m. (XNUMXst module)
  • Course duration: 3,5 – 4 hours per module
  • Participants can attend the entire course series or individual modules.
  • Costs: Module 1 is free; Modules 2 to 5 can be attended for a course fee of €150 per module or €500 for the entire course series

REGISTRATION
Register now and take the first step towards successful certification and market entry.
www.medunigraz.at/crash-course-regulatory-requirements

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