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. In the event of a classroom-based course being deemed unsafe, your training booking will be automatically transferred to online delivery using our highly-interactive virtual classroom - Connected Learning Live.

If you have any questions regarding your booking, please contact training@bsigroup.com or call +44 345 086 9000.


Booking a course delivered via Connected Learning Live?

Take advantage of our exclusive offers, only available in July and August 2020*

Book a July or August Connected Learning Live course date and you’re entitled to unlock one of the following benefits:

  • Option 1: Get 50% off a second delegate booking fee
    Offer applicable to public courses delivered via Connected Learning Live in July and August 2020 only. Second delegate must attend the same course date
  • Option 2: Save £500 on a BSI Diploma in Quality Management
    Offer applicable to delegates that have booked a public course delivered via Connected Learning Live in July and August 2020 only

Contact our training team today to find out more and book your place. Call +44 345 086 9000 or email training@bsigroup.com

*Terms and conditions: Applies to all public BSI UK training courses, taking place in July and August 2020 via Connected Learning Live only. Call our training team on +44 345 086 9000 or email training@bsigroup.com for more information. Second delegate must attend the same course date as the first delegate. Moves, changes and cancellations are not permitted. Payment required or invoice issued at the time of bookings. This offer does not apply to BSI re-sellers or Cybersecurity and BRCGS courses. Offer is for new BSI UK training bookings only. Offer is not to be used in conjunction with any other offer. Offer subject to availability of training courses. Bookings are non-transferable. All other terms and conditions for training courses apply.