EU-MDR

Introductory course
EU-MDR and ISO 13485:2016

Introduction to the impact of the European regulation on medical devices (EU-MDR 2017/745) and ISO 13485:2016 requirements

TARGET AUDIENCE

The course is intended for anyone who wants to understand the impact of the European regulation on medical devices and review the requirements of ISO 13485:2016: quality managers, regulatory affairs, production, R&D, purchasing teams... It concerns any type of organisations: medical device production companies, distributors and importers of medical devices.

The maximum number of participants is 10 people.

GOALS

  • Understanding the impact of the EU Medical Devices Regulation 2017/745 and be prepared for those changes
  • Understanding the essential requirements of ISO 13485:2016

COURSE CONFIRMATION

Each participant will receive a certificate of participation from Bureau Veritas Switzerland AG when participating completely.

CONTENT

Developing an understanding of the implications of EU MDR and ISO 13485

Gefälschte Zertifikate
  • New/Updated processes from EU MDR 2017/745
  • Risk management according to ISO 14971:2019 and ISO 24971:2020
  • MDR for the complete lifecycle
  • Certification Audit
  • Technical File content
  • ISO 13485 and its requirements
  • Exercises

Following this training, other days may be suggested to go into more detail on the implementation of clinical investigations and data management that this European regulation implies.

DETAILS

Date: 15.12.2020 [ATTENTION: Change of date! Former date was 30.10.2020]

Time: 9 am to 5:30 pm

Place: CVCI Chambre vaudoise du commerce et de l'industrie, Avenue d'Ouchy 47, 1006 Lausanne

Price: CHF 900.00

REGISTRATION

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

We are looking forward to meeting you!

DO YOU HAVE ANY QUESTIONS?

CONTACT US