Technical Documentation and Conformity Assessment for Medical Devices

On-Demand

Technical Documentation and Conformity Assessment for Medical Devices

Level Specialist Duration 4 hours

Available to book: On-demand elearning Book your place

This 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

BSI’s on-demand courses are market-leading and available 24/7. Developed by top subject matter experts, they contain the same high-quality content you will find in our tutor-led training, but with the added benefit of being able to learn at your own pace and at any time.

How will I benefit?

This course will help you:

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

You will learn about:
- 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
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.
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

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