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Urgency: 7-14 days
Industry: Consulting and Advisory Services
Description: Medical Devices Consultant needed for guidance with testing of indirect patient contact components in medical devices. Specifically, we would like to understand if you have any experience and your recommendations for testing of components that contact the gas path and/or breathing system in an anesthesia machine. FDA currently considers gas path/breathing systems components as "externally communicating" components that must be demonstrated as nontoxic. Testing according to ISO10993 does not address this level of contact, we are seeking advise on appropriate testing methods.
Required Laboratory Location: Anywhere
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