AAMI, FDA Release Preview of S3 Challenge Agenda
The Association for the Advancement of Medical Instrumentation (AAMI) and the Food and Drug Administration (FDA) have announced the S3 Challenge will return in 2015 with a focus on a popular standard related to managing risk. The event will be held April 1-2, 2015 in Herndon, Va.
Join colleagues from across the medical technology industry and work to solve some of the most vexing issues surrounding the use of global standards. Participate in open, intense discussions, analyze problems, and formulate solutions that result in safer and better performing medical devices while reducing time to market.
The discussion for 2015 will focus on IEC 60601, specifically on electrical and mechanical hazards and the importance of assessing and managing risk as a part of design, good manufacturing, and premarket and postmarket performance of medical devices.
The two-day event will be organized into four half-day sessions on:
• Issue #1 – Construct of the 60601 Series
• Issue #2 – Electrical Hazards
• Issue #3 – Mechanical Hazards
• Issue #4 – Making the Case of Conformance
This is an invaluable opportunity for you to fully communicate your organization’s perspective on the issues that complicate standards and compliance-and then brainstorm with industry colleagues and FDA staff to recommend actions that can make standards more workable and implementation more consistent.
For full details and to register, visit the conference home page.
Source: AAMI
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