Clinical Evaluation & Post-Market Surveillance Course
2-day Clinical Evaluation and Post-market surveillance course
This course focuses on the application of key methods to ensure that the requirements of the new Medical Device Regulation are met.
This course is designed to enhance the level of understanding for those actively involved with the creation and maintenance of clinical evaluation and post-market surveillance files. Our expert tutors give you the necessary skills to ensure all the requirements of the law are met and an insight into how the clinical evaluation is integrated with risk management, post-market surveillance, the periodic safety update report, the summary of safety and clinical performance, trending and the CAPA system.
By the end of this practical and interactive course, delegates are able to understand the theory of planning and producing a clinical evaluation report and conducting effective post-market surveillance which will meet the requirements of the law.
Content includesThis course is a practical guide to assembling a clinical evaluation plan and report in accordance with the requirements of the Medical Device Regulation. Additional requirements and the gap between the current Medical Device Directive and the regulation. How to go from the stated objectives:
- Risk v benefit
- Literature review
- Clinical investigations
- Alternative therapies
- Other claims made by the manufacturer
- To conclusions which address each in turn
This course also explores the interactions between clinical evaluation and post-market surveillance and how they influence other aspects of the quality management system.
- A practical guide to post-market surveillance
- Planning PMCF
- Sorting devices by risk
- Implementing PMS/PMCF
- Dealing with adverse events
- Trending and reporting