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Article: 'Checking up' on medical electronics: a healthy relationship involves understanding FDA documentation.(Medical Electronics Assembly)
- Article from:
- Circuits Assembly
- Article date:
- October 1, 2008
- Author:
CopyrightCOPYRIGHT 2008 UP Media Group, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Medical electronics assembly demands a different set of criteria than do commercial PCBs. In particular, the US Food and Drug Administration (FDA) requires specific documentation, especially for verification of certain processes. Complying with FDA-approved documentation is considerably easier when an EMS provider is ISO 13485 certified. The reason: the considerable traceability embedded in the standard.
Beyond FDA documentation, today's medical electronics assembly also requires special testing, avoiding obsolete components and a detailed evaluation of a Pb-free product, as a looming EU RoHS Directive is expected to include medical electronics.
The FDA ...