MDSAP Compliance
One Audit, Five Markets. Streamline your global market access.
The Challenge
Common pain points that prevent medical device manufacturers from achieving sustainable compliance.
Multiple Audit Burden
Dreading multiple audits from different regulators (FDA, TGA, HC) every year?
Regulatory Mapping Complexity
Struggling to map ISO 13485 requirements against country-specific regulations?
Single Point of Failure
Fear of a single audit failure jeopardizing all your international markets?
The VigilaMed Solution
MDSAP Audit Model Integration
We align your QMS to the MDSAP audit model, integrating the specific requirements of the US, Canada, Brazil, Australia, and Japan into a single, robust system.
Manufacturing-First Methodology: Our MDSAP approach consolidates multiple country requirements into one unified quality system, reducing audit frequency and complexity while maintaining full compliance.
What You Get
Tangible deliverables that deliver immediate value and long-term compliance.
- MDSAP Gap Analysis Report
- Country-Specific SOP Supplements
- Audit Readiness Plan
- MDSAP Audit Preparation Guide
- Post-Audit Remediation Support