Transparency and the New Medical Device Reporting Rules – Webinar Recording/Transcript
Transparency and the New Medical Device Reporting Rules: What to Do Now That ASR is Really Over
Do you have a handle on the changes you may have to make to your MDR
program as a result of the Voluntary Malfunction Summary Reporting (VMSR) program?
And do you know how the FDA’s National Evaluation System for Health Technology (NEST) will impact you?
If you’re at all unsure, this presentation will deliver exactly what you need to ensure your organization’s MDR program is keeping pace with the changes brought by VMSR and NEST.
Two authorities from BioTeknica, Inc. — Julie Larsen, Principal Consultant and Director of Inspection Readiness Services and Lenita Sims-Spears, Esq., Senior QARA Consultant — will explain the implications for your organization and what to do to ensure you remain compliant.
- The real-world impact new medical device reporting programs will have following the formal end to the ASR program.
- How the FDA is transitioning to the VMSR program.
- Which devices and device malfunctions are eligible, or not, for summary reporting in VSMR.
- Which events still require individual malfunction reports.
- How to request summary reporting in VMSR.
- The critical components of FDA’s NEST initiative — including how the agency will deploy real-world data to rapidly identify and address safety signals for devices on the market.
- How the FDA will monitor medical device performance through NEST.
This presentation is the best way to understand the reporting process updates you may need to make so you can keep pace with VMSR and NEST.