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MD SAP Toolkit

Medical Device Single Audit Program compliance

Documentation for the Medical Device Single Audit Program (MDSAP), covering quality management system requirements across participating regulatory jurisdictions for medical device manufacturers.

What's inside

  • MDSAP quality management system manual
  • Auditing organization and regulatory authority mapping
  • Process validation and risk management templates
  • Management review and internal audit checklists
  • Corrective action and preventive action (CAPA) records

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Preview the drafting quality of the MD SAP Toolkit with three real sample documents. Sign in and we'll email the full demo pack straight to your account address.

  • DOCX

    MDSAP Governance Policy & RA Liaison

    An editable governance policy defining regulatory authority liaison responsibilities for MDSAP oversight.

  • DOCX

    MDSAP AO Performance Indicators Tracker

    A structured tracker for monitoring auditing organization performance indicators and follow-up actions.

  • XLSX

    MDSAP Scope of Certification Determination Worksheet

    A working worksheet for defining and documenting the applicable MDSAP certification scope.

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