A required part of conformity assessment and CE Marking is the need for technical documentation which includes the collation of supporting information about your medical device. Technical documentation is maintained throughout the product lifecycle. Learn how to assemble this and other types of required information so you can CE Mark your device in Europe.
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
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
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
What is included?
- Detailed training course notes
- A loan copy of the standard, for use during the course
- Internationally recognized BSI Training Academy certificate
Prior knowledge and learning
You should have a basic understanding of European Medical Device Regulation (MDR).