This course will help you to implement the requirements of European Medical Device Regulation (MDR) to obtain and maintain CE marks for your product, giving you access to a market with 500+ million people. Find out best practice for assembling Technical Documentation and QMS when placing Medical Devices (MD) on the European Union market.
The course will also review the requirements of, and relationship between, the legal manufacturer, subcontractors/suppliers, notified bodies (e.g. auditing), and economic operators (importers, distributors, EU Representatives) according to their obligations by MDR.
Online training: Connected Learning Live
Do you prefer the convenience of online training? View here for this training course or read more about Connected Learning Live.
Combination discount MDR training courses
Attending several medical device courses is associated with special discount.
| Investment | Discount | |
| Transition or requirements MDR - IVDR | €800 | |
| Implementing CE Marking MDR - IVDR | €2.150 | |
| Total | €2.950 | |
| Combination training course | €2.850 | €100 |
In-house training courses
We can deliver this training course to your team in-house. Training in-house allows you to save on each individual delegate and also cut out travel and accommodation expenses, which can be significant.
For more information about the in-house training or to request a quote, please contact Training via +31 (0)20 346 0780 or send an email to training.se@bsigroup.com.
Who should attend
The course is especially suitable for:
- RA, QM, and QA professionals who need to implement the MDR
- Anyone concerned with certification or active in projects for CE-marking
- Staff working for organizations that partner with Medical Device manufacturers e.g. as subcontractor, crucial supplier, OEM, Authorized representative, importer, distributor, auditee
Please note: This course will not cover implementation for In Vitro Diagnostics or concentrate on devices with specific requirements.
Prerequisities
Participants must have a good understanding of the requirements in the MDR, which is conveyed by our 1 day Requirements of the MDR course or our MDD to MDR transition course.
Participants should also have either experience with, or basic knowledge, of quality management systems for the medical device industry, or good understanding of European Medical Device legislation, or some experience in pre-or post-market activities within the EU.
Practical information
- It's a 3-day course
- The training will be delivered in the Dutch language (or in English when by all delegates required/approved)
- The materials will be provided in English
- Lunch and drinks are included
For further information regarding reduced rates at the hotel where the training is being conducted please contact training.se@bsigroup.com or 0031-(0)20-346 0780.
