Circuits Assembly - October 2008 - (Page 24)

Medical Electronics Assembly ‘Checking Up’ on Medical Electronics By Zulki Khan A healthy relationship involves understanding FDA documentation. edical 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 is the US’s governing body for approving medical electronics devices intended for monitoring or intervening with the human body. Consequently, FDA approval for work performed by medical electronics OEMs and EMS providers is a tightly controlled process involving precise documentation covering audits, design capability evaluation and verification. Improperly documented, incorrect or incomplete information stemming from design has adverse effects during assembly processes and FDA approvals. Among other things, an FDA audit includes when design reviews are documented, how comprehensive these reviews were, and the type of a design’s systematic examination, which is 24 Circuits Assembly OCTOBER 2008 M performed to evaluate the adequacy of design requirements and changes. The FDA also evaluates a design’s capabilities to identify problems it is intended to resolve. Normally, to meet this objective, medical OEMs perform informal technical reviews within the design team. But these reviews are then followed by more formal technical issue reviews and feedback from non-development design team members. That’s important, because design and documentation reviews begin with an examination of the development plans. When the FDA looks at the specification and its documentation, it is checking into design specification changes, listed testing plans and procedures, and other associated documentation and activities associated with a given project. Verification is expected at each step of the different lifecycles of medical changes and implementations. Results validation is then conducted to prove overall efficiency of a medical device. Hence, there are considerable documentation stages and detailed procedures an OEM or EMS provider needs to know. They need to ensure all revision and specification changes are properly documented with dates, specific details and proper signoffs. Take, for example, a design change involving a slightly higher speed component. In this case, the original component had a 6 ns rise time, which was then changed to 3 ns. It’s best to use the same component manufacturer to maintain similar markings so that the part number shows one or two decal changes and represents a minor change. If the EMS provider is not careful in documenting circuitsassembly.com http://www.circuitsassembly.com

Table of Contents Feed for the Digital Edition of Circuits Assembly - October 2008

Circuits Assembly - September 2008 Contents Letters Caveat Lector Industry News Market Watch Talking Heads Global Sourcing Screen Printing Better Manufacturing 'Checking Up' on Medical Electronics Solder Ball Attachment Using Laser Soldering Improving QFN Reliability Reflow Soldering Tech Tips Test and Inspection Process Doctor Pb-Free Lessons Learned Alternative Energies Eastern Advances Product Spotlight Ad Index Assembly Insider Technical Abstracts

Circuits Assembly - October 2008

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