MDSAP Compliance Consulting
The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to undergo a single regulatory audit of their QMS that satisfies the requirements of multiple regulatory jurisdictions, including the USA (FDA), Canada (Health Canada), Brazil (ANVISA), Japan (MHLW/PMDA), and Australia (TGA). Our MDSAP consulting services help you align your QMS to these stringent multi-jurisdictional requirements, conduct gap assessments, and prepare your organization for the official auditing organization (AO) assessment.
Key Benefits
- Access multiple major global markets simultaneously
- Reduce the number of regulatory audits you undergo
- Minimize disruptions to your manufacturing operations
- Demonstrate a world-class commitment to quality
Recognized Standards
Our Methodology
Gap Assessment
Evaluate current QMS against MDSAP requirements for all target jurisdictions.
QMS Upgradation
Implement necessary procedures and controls to satisfy specific country requirements.
Internal Audit
Conduct a mock MDSAP audit to ensure full compliance before the official assessment.
AO Audit Support
Provide expert support during the certification audit by an Auditing Organization.
Required Documents
Common Questions
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