Introductory course
EU-MDR and ISO 13485:2016

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

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: TBD

Time: 9am - 5pm 

Place: Virtual

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!

Disclaimer 
If the number of registered participants does not reach the minimum required, the training might be rescheduled. If that is the case, we will inform you ahead of time and offer an alternative date. 

Related Courses

Due to the current situation we are offering more courses that are related to this topic virtuell: 

• 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.