This one-day intensive course enables greater understanding of the key requirements for technical documentation for medical devices, in line with the European Medical Device Regulation (MDR) requirements in Europe. The aim of the course is to enable manufacturers to:
- Create robust technical documentation to demonstrate compliance to the MDR
- Better understand regulatory requirements and Notified Body expectation, to prevent unnecessary delays to the certification process
Online training courses: Connected Learning Live
You can attend this training course classroom based and online. Do you prefer the convenience of an online training course? View here for the available dates or read more about Connected Learning Live.
Who should attend?
QA/Regulatory personnel involved in compiling technical documentation; product design personnel and those in research and development for medical devices intended for the European market.
Prerequisites
You should have a basic understanding of European Medical Device Regulation (MDR).
What will I learn?
Upon completion of this training, you will be able to:
- Confirm the technical documentation requirements as specified in the MDR and relevant guidance documentation
- Interpret the MDR in relation to the technical documentation requirements
- Define the process enabling the creation and maintenance of compliant technical documentation
- Grasp how standards and guidance can be used to improve your technical documentation
- Recognize what is expected by Notified Bodies for technical documentation during reviews and be better prepared
- Recognize the documentation requirements during the product lifecycle and the post-market updates needed
Practical Information
- This is a 1-day training course
- The training will be given in both Dutch and English, please check the specific dates for the language.
- The training material is in English
- Including coffee/tea facilities, lunch
Would you like to spend the night in the hotel before or during the training? We can reserve a hotel room for you at a reduced rate. If you would like to make use of this possibility, please contact us via training.se@bsigroup.com.
In-house training courses
The training courses from the regular training offer can also take place at your location. These can be individual training sessions from the portfolio or a combination of training sessions. In most cases, the training courses can be given in both English and Dutch. Advantages of an in-house training:
Your employees:
- Save on travel time & costs;
- receive the same message;
- train with the same material;
- practice with the same interactive assignments;
- train when it suits them.
For more information about in-house training, please contact Training on 020-346 0780 or send an email to training.se@bsigroup.com.
