Post market surveillance is changing, not only in the US, but also in the EU and Canada. New rules and regulations are emerging in the countries where the devices manufacturers market their products. The sheer volume of rules and regulations can be daunting, but the differences in each geographic market can be scary.
This webinar explains the aspects of post market surveillance that will help you understand and implement them. The webinar explains the use of post-market surveillance in maintaining your risk management file (ISO 14971) and updating your clinical evaluation (MDD Annex X). In addition, the webinar compares and contrast the rules for adverse event reporting in the US, EU, and Canada.
Who Will Benefit:
This webinar provides information that is valuable for people involved in monitoring product performance, maintaining risk management files, updating clinical evaluation, and reporting to regulatory agencies. This typically includes:
- Quality Managers
- Regulatory Affairs Managers
- Risk Managers
- Design Control Managers