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STRYKER

S3 MedSurg Bed

Stryker Medical’s S3 MedSurg bed had been the standard of care in hospitals for more than a decade, during which FDA compliance requirements had changed. So, when Stryker planned to introduce its next-generation S3, implementing a new sub-system approach, it had to be brought up to the new 3rd edition IEC 60601-1 standard. To help accomplish this, Stryker contracted with Garrett Technologies, Inc. to map gaps between the existing IEC 60601-1, 2nd edition certification to the newer 3rd edition requirements, and to act as Stryker’s agent for interactions with the appropriate approval agencies (UL).

WE DELIVERED

  • Review of current documents: forms, BOMs, risk management files, product operating manuals, 2nd edition reports, and prior UL TRF's for IEC 60601-1 certifications

  • 2nd to 3rd edition gap analysis for the product

  • Assessing compliance to 3rd edition for 60601-1, 60601-1-2,, 60601-6, 62366, 60601-8, 60601-2-38, 60601-2-52

  • Assessing 14971 requirements relevant 60601-1 3rd Edition

  • Managed agency testing

  • Managed agency reports

 
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