Technical Documentation for Medical Devices According to the MDR
BSI will learn you how to create robust technical documentation to demonstrate compliance to the MDR and better understand regulatory requirements and Notified Body expectation, to prevent unnecessary delays to the certification process
Purpose and Outcome
This one-day 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 and better understand regulatory requirements and Notified Body expectation, to prevent unnecessary delays to the certification process.
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
Who should attend
Regulatory personnel involved in compiling technical documentation; product design personnel and those in research and development for medical devices intended for the European market.
Prerequisite: You should have a basic understanding of European Medical Device Regulation (MDR).
Marc Klinkhamer - BSI tutor
"Liked the fluctuation between lecture and tasks. The involvement of all participants and commitment of lecturer"
"It provides an overview of MDR technical documentation structure"
"The instructor was very good"
"Very well organized, good presenter"
"I liked the atmosphere created despite it being a digital form"
Participants, Spring 2021