ISO toolkit

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