Course Details
The aims and learning outcomes of this course are:
- To understand the European Regulation for Medical Devices.
- To appreciate the EU requirements for selling Medical Devices.
Following completion of this course, participants should:
- Understand the European Medical Device Regulation.
- Be able to actively participate in preparing documentation for technical files.
- All participants should have a working knowledge of the requirements.
This course is held over three or four days, depending on whether a certificated examination is required at the end of the course. Participants will fully engage with the lecturer through group and individual exercises. There are plenty of opportunities to ask questions and the course can be fully tailored to the company’s products and internal structure.
This eight module course explores the European Medical Device Regulation.
- Introduction.
- Other articles.
- Classification & Conformity.
- Risk.
- GSPRs.
- Clinical Evaluation.
- Post-Market.
- Compliance.