Q1 Productions EU Medical Device Post-Market Clinical Evaluation Planning Conference (April 19-20, Paris) On-Demand Panel Discussion
This recorded panel discussion will be available on demand soon.
About This Webinar
Post-market surveillance (PMS) is a requirement for medical device manufacturers and a critical element of EU MDR. The regulation calls for manufacturers to develop and maintain active and systematic post-market surveillance systems to support safety and performance throughout a medical device lifecycle. PMS aims to provide feedback on the benefit-risk determination, clinical evaluation, usability, safety and clinical performance, reportable trends, and technical documentation. Much of this insight and data can be sourced through scientific literature.
But how can you develop a robust surveillance program supported by unprecedented volumes of research and ever evolving grey literature?
Key Learning Objectives:
But how can you develop a robust surveillance program supported by unprecedented volumes of research and ever evolving grey literature?
Key Learning Objectives:
- Understanding the relationship between risk, post-market surveillance requirements, and performance evaluation.
- Leveraging transparency and compliance for literature reviews in the post-market surveillance context.
- Employing automation and smart workflows to effectively monitor clinical literature and databases.
- Implementing best practices for literature reviews supporting a post-market surveillance quality management system.
- Considering operational efficiencies to streamline data gathering and analysis.
Duration: 1 Hour
Watch the Webinar
Speakers
Dr. Michal Slomczykowski
Medical Director at Geistlich Pharma
Severin Fürhapter, PhD
Head of Hearing Science and Clinical Research at MED-EL
Peter O'Blenis
CEO at DistillerSR
Dr. Bassil Akra
Founder & CEO AKRA Team GmbH