MDSAP (Medical Device Single Audit Program)
The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to undergo a single regulatory audit that satisfies the quality management system requirements of multiple regulatory authorities. MDSAP is recognized by regulators in the United States, Canada, Brazil, Australia, and Japan.
Under MDSAP, manufacturers must demonstrate compliance with ISO 13485 along with country-specific regulatory requirements. Chitransh Groups Pvt. Ltd. provides expert consulting support to help organizations successfully prepare for and maintain MDSAP compliance.
Our MDSAP Services
- MDSAP gap analysis and audit readiness assessment
- ISO 13485 and country-specific regulatory alignment
- QMS documentation preparation and review
- Employee training on MDSAP requirements
- Internal audits and mock MDSAP audits
- Support during certification and surveillance audits
Benefits of MDSAP Certification
- Single audit accepted by multiple regulatory authorities
- Reduced audit costs and regulatory burden
- Improved global market access
- Stronger quality management and compliance culture
- Enhanced regulatory confidence and transparency
Why Choose Chitransh Groups?
Our regulatory experts have hands-on experience with MDSAP audits and global regulatory requirements. We provide practical, compliant, and cost-effective solutions to help manufacturers achieve successful MDSAP certification and maintain long-term compliance across multiple markets.
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