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Request a Polarion Demo for ISO 13485
Key Aspects of ISO 13485 Medical Devices
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Functional specification of use
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User requirement specification
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Specification for specific configuration
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Single view of validation status of all systems both operational and performance related
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Support automated and manual testing
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Traceability Reports
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Problem reporting, non-conformances, and CAPAs
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Faster audits
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Other Links for ISO 13485
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