DUBLIN--(BUSINESS WIRE)--The "Clinical Evaluation of Medical Devices: The Clinical Evaluation Report" conference has been added to ResearchAndMarkets.com's offering.
This two day course will cover all the aspects of clinical evaluation in line with the European Medical device regulations and applicable guidance documents.
The course will provide you with the tools and skills you will need to produce a high quality clinical evaluation report for all your medical devices. You will understand the detail of what clinical data is needed, how to collect it, analyse it and produce a clinical evaluation report that is acceptable to the Regulatory Authorities and Notified Bodies. You will learn how the process fits into the development of a medical device and also the post market aspects of clinical evidence.
The course includes case studies and template documents which you will be able to utilise to produce your own high quality clinical data evidence documentation.
Agenda
- Objectives and overview
- What is a clinical evaluation?
- Why and when is it necessary to conduct a clinical evaluation
- Who and what is involved in the clinical evaluation process
- Workshop - Bringing it together
- What regulations govern clinical evaluations and what guidance documents should clinical evaluations be conducted to
- Quiz
- Q & A and wrap up of day one
Programme - Day Two
- Review of day one, introduction to the day, objectives and overview
- Documentation necessary for conducting a clinical evaluation
- The literature review process
- The Clinical Evaluation Report (CER)
- What is state of the art and how to conduct a risk benefit assessment of the data
- Impact of the Medical Device Regulations (MDR)
- Quiz
- Q & A and wrap up
For more information about this conference visit https://www.researchandmarkets.com/research/ls4ngd/2day_course?w=4
