Medical Device Studies: Clinical Evidence is a conference dedicated to gathering and using clinical evidence for CE marking and post market compliance.
Topics
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
