Medical Device Postmarketing Vigilance Reporting: Update and Expectations for Manufacturers is a webinar that covers topics such as:
- Recognize the "new" terminology and concepts
- Examine the latest changes to MEDDEV and Medical Device Vigilance and impact on medical device manufacturers
- Examine why Global Harmonization Task Force (GHTF) is an integral component of the new postmarketing vigilance guidelines
- Report incidents as recommended by the guidance
- Recognize which amendments impact the European vigilance system
- Manage expectations for reporting and timelines
- Submit periodic summary reports of incidents to Competent Authorities
- Interpret the new guidelines that cover incidents involving devices that carry the CE mark and devices that do not carry the CE mark
- Identify the conditions under which reporting is not required and why they have been expanded and clarified with no significant changes, although one reason has been removed
- Examine controversial aspects of the guidelines, including the extension of their scope and the new approach of immediate reporting unless delays can be justified
Medical Device Postmarketing Vigilance Reporting: Update and Expectations for Manufacturers brings together attendees from device companies in involved in vigilance reporting, including Regulatory Affairs, management and departmental representatives, Quality and Compliance, Clinical Affairs, Distributors, Marketing & Sales, Consultants and Engineering/Technical Services/Operations.
