MDSAP (Medical Device Single Audit Program)
MDSAP (Medical Device Single Audit Program) allows medical device manufacturers to undergo a single regulatory audit that satisfies the requirements of multiple regulatory authorities. This efficient approach saves time, reduces costs, and ensures compliance with international standards.
What is MDSAP?
The Medical Device Single Audit Program (MDSAP) is an international initiative led by the International Medical Device Regulators Forum (IMDRF) to standardize quality management system audits. It enables recognized auditing organizations to perform a single audit of a medical device manufacturer that covers the requirements of multiple jurisdictions:
- United States FDA
- Health Canada
- Australia TGA
- Brazil ANVISA
- Japan MHLW and PMDA
Why is MDSAP Compliance Important?
Compliance with MDSAP is essential for medical device companies targeting multiple international markets. It:
- Helps manufacturers maintain compliance with ISO 13485 standards
- Builds trust with regulatory bodies across key markets
- Enhances transparency and consistency in regulatory processes
- Helps manufacturers maintain compliance with ISO 13485 standards
Our MDSAP Services
At liscorav, we help you navigate the MDSAP audit process efficiently. Our team provides:
- Gap analysis and readiness assessments
- Implementation of QMS per MDSAP and ISO 13485 requirements
- Internal audits and mock inspections
- Documentation preparation and audit support
- Continuous compliance monitoring and updates
Each device class has specific regulatory requirements based on its risk level.
Why Choose Lisora for MDSAP Compliance?
Expert Consultants
We have deep experience with global regulatory frameworks
Customized Solutions
Tailored services based on your product and target markets
End-to-End Support
We offer complete documentation to audit defense
Proven Track Record
Successful MDSAP implementation for leading manufacturers
