Technical Documentation for the Medical Device Regulation (MDR)

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

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.

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

How will I benefit?

This course will help you to:

  • Ensure auditable technical documentation meets regulatory requirements and demonstrates product safety and performance
  • Reduce delays to product certification by providing complete and compliant documentation
  • Reduce costs by reducing audit questions and nonconformities, thereby streamlining the certification process

What's included?

  • You will gain 8 CPD points on completing the course
  • Internationally recognized BSI Training Academy certificate
  • Training course notes
  • Lunch
  • Refreshments

 

In-house training

If you have a group of people to train and a single location that is practical, an expert tutor can deliver training at your premises. Want to know more?

 

Request an in-house training quote >


COVID-19: Important information on classroom-based training courses

BSI is closely monitoring UK Government Advice regarding the safety of classroom-based training courses. We’ve been working with all our venues to ensure that COVID secure measures are in place and a member of our team has visited each venue to personally check things over. Enhanced cleaning procedures have been implemented, food and beverage offers adapted, and meeting room layouts have been modified to enable socially distanced events – with anti-bacterial gel and wipes readily available.

If you have any questions regarding your booking of a classroom-based training course, please contact training@bsigroup.com or call +44 345 086 9000.