Course description
This one-days 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
Upcoming start dates
Suitability - 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.
Outcome / Qualification etc.
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
Training Course Content
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
Course delivery details
- You will gain 8 CPD points on completing the course
- Internationally recognized BSI Training Academy certificate
- Training course notes
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BSI, the British Standards Institution, is one of the world’s leading providers of training, certification, standards, regulatory approval, business improvement and management development for local and global audiences.
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