Introduction to
ISO 13485:2016 & EU-MDR (2017/745)

Introductory course

TARGET GROUP & PREREQUISITES

This course is designed for anyone who wants to understand the implications of the European Medical Device Regulation (EU MDR) and to review the requirements of ISO 13485:2016: Quality Managers, Regulatory Affairs, production, R&D, Purchasing teams, ... 

It concerns any type of organization: from medical device manufacturing companies to medical device distributors and importers.

Goals

  • Understand the impact of the European Medical Device Regulation: Grasping the regulatory changes of the new EU MDR Review 2017/745.
  • Understand the essential requirements of ISO 13485:2016

Content

Gefälschte Zertifikate
  • The new EU Medical Device Regulation EU-MDR 2017/745: Identifying key changes
  • Risk management according to ISO 14971:2019 and ISO 24971:2020
  • The EU MDR for the entire life cycle
  • Certification audit
  • Contents of the technical file
  • ISO 13485:2016 and its requirements
  • Exercises

Course Data

DATESDURATIONTIMESLOCATIONLANGUAGEPRICE (EXCL. VAT)
tbd2x 0,5 Days9am - 1pmVirtual (Teams)tbdtbd

REGISTRATION

To register for this course, please fill out the registration form below. You will then be contacted by us regarding confirmation of registration and further processing.

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