The objective of the training:
Our training program, which is an indispensable part of your technical file and which has been prepared according to Rev.4 MedDev 2.7.1. of Clinical Data Evaluation Report whose importance is increasing with MDR, will support you in your challenges with DR, and will cover the topics of “Post-Market Monitoring” (PMS) “and” Post-Market Clinical Follow-up “(PMCF) in the same training.
The content of the program:
- What is Clinical Data? What does it consist of?
- What is a Clinical Evaluation?
- What is the Clinical Evaluation Guideline?
- What are the sources of documents and data used in Clinical Evaluation?
- Appraisal of clinical data
- Analyzing clinical data
- Writing the clinical evaluation report
- What are the important terminologies used in clinical studies?
- What is PMS?
- What is PMCF and What t is Not?
- Major changes that have appeared with MDR
Program Duration: 8 Hours