Medical Device Studies: Clinical Evidence is a conference dedicated to gathering and using clinical evidence for CE marking and post market compliance.
Medical Device Studies: Clinical Evidence covers topics such as:
- Clinical Evaluations (Literature Review )
- The regulatory requirements and guidance applicable to clinical evidence
- What is required in terms of clinical data post CE mark
- What is required in terms of clinical data prior to CE marking
- How to conduct a clinical investigation
- What documentation is needed for pre- and post market phases of clinical data collection
- How to prepare regulatory notifications to the Competent Authorities and obtain other necessary approvals
- How to conduct a post market clinical follow up study
- Practical tools on how to write a final study report for a regulatory clinical investigation
- The key aspects of pre and post market study set up, management, monitoring and close down
- Knowledge on how to provide the right clinical evidence throughout the product life cycle that meets the requirements of regulatory bodies and other interested parties
- How to prepare a paper or presentation for publication and marketing
Medical Device Studies: Clinical Evidence will be held on 18-21 Mar 2024.
