Stability – Medical Devices Webinar

The Medical Device Regulatory Convergence Project, co-led by USAID, ANSI, and AdvaMed through the Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector, in collaboration with the U.S. Food and Drug Administration (FDA), hosted a webinar on June 1 to present “Fundamentals of establishing sterile barrier systems for medical devices: package stability (shelf life) and package performance” the “Considerations for assessing use-life of reusable devices”, presented by Steven Turtil and the “Assessing device performance for the labelled shelf-life”, presented by Limin Sun.

The agenda, presentations and recorded session are available below.

Agenda

Recordings

Presentations

MEDICAL DEVICE STABILITY – Conducting Package Stability and Performance Validation for Terminally Sterilized Single-Use Medical Devices — and — Establishing Use-Life for Reusable Medical Devices – Steven Turtil , US FDA

Assessing device performance for the labelled shelf-life – Limin Sun, US FDA