This seminar gives you guidance on how to structure the technical documentation of your medical devices in a systematic manner and keep it up to date. Your technical documentation not only must be in compliance with the legal requirements, but should also be designed to ensure smooth cooperation with the Notified Body, for example in the conformity assessment procedure for CE marking. You become familiar with the key elements of technical documentation and learn why risk analysis is an integrated part thereof. The contents are explained on the basis of practical examples, which makes it easier to transfer them to your own company.
- Overview of the required contents and structure of technical documentation for medical devices
- New legal framework for medical devices in the EU
- Technical documentation and conformity assessment procedures
- Technical documentation and competent authorities
- Contents and structure of technical documentation
- Control and availability of technical documentation
- Technical documentation for OEM medical devices
- The key elements of technical documentation
- Risk analysis
- Proof of sterility assurance
- Stability in storage and transport
- Clinical evaluation
- Documentation management
- Employees in charge of, or involved in, the creation of technical documentation for medical devices
- Personnel in regulatory affairs
certificate of attendance TÜV SÜD Akademie
This seminar forms part of modular qualification. Following successful completion of the advanced modules, you can obtain the following recognised qualification:
- Manager Regulatory Affairs International – TÜV
TÜV SÜD Akademie senior expert trainers
- Obtain proof of compliance with the EC Directive for the technical documentation of your medical devices.
- Acquire knowledge of the content and structure of technical documentation for medical devices.
- Learn how to create your own legally compliant technical documentation.