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
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.
- 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
Each participant will receive a certificate of participation from Bureau Veritas Switzerland AG when participating completely.
Developing an understanding of the implications of EU MDR and ISO 13485
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.
Price: CHF 900.00
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!
Due to the current situation we are offering more courses that are related to this topic online:
- MDR classification and technical documentation
- MDR and the risk-based update loop for manufacturers
- MDR Pharmacovigilance
- MDR for subcontractors
- MDR for dealers, importers and authorized agents
If you are interested in any of the courses as listed above, please contact us.