This template helps organizations document and justify the inclusion or exclusion of specific clauses from the ISO 13485 scope, providing clarity on the applicability of various requirements based on the organization’s activities and processes.
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All GovernanaceDocs documents are developed based on well-known standards such as NIST CSF, ISO 27001, ISO 22301, PCI-DSS and HIPAA.
Hence, You just need to download and selected document and add your company name and logo.
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