EC Medical Devices Vigilance System and Post Marketing Surveillance is a conference dedicated to ensuring patient safety.
EC Medical Devices Vigilance System and Post Marketing Surveillance covers topics such as:
- How to apply the reporting rules with real examples
- The EU Vigilance process
- The expectations from Competent Authorities in Field Safety Corrective Actions (FSCA)
- The legal obligations for your company
- The importance of the Risk Management process
- What a Notified Body expects from an audit on PMS Systems
- The role of Notified Bodies in Vigilance
- How various Member States handle vigilance reports
- The recast of the Medical Device Directive