Medical Device Single Audit Program (MDSAP) Services
Expert MDSAP Support for Medical Device Manufacturers
The Medical Device Single Audit Program (MDSAP) allows a recognized Auditing Organization to conduct a single regulatory audit that satisfies the quality management system requirements of multiple participating regulatory authorities. The program was established to promote harmonization, reduce duplication of audits, and improve regulatory efficiency for medical device manufacturers.
For manufacturers operating in multiple jurisdictions, managing separate audits and regulatory requirements can be resource-intensive and time-consuming. MDSAP addresses this challenge by enabling manufacturers to undergo one audit process that can be accepted by participating authorities.
Cert3Global provides practical and structured support to help manufacturers prepare for MDSAP audits, identify quality system gaps, and implement processes that align with regulatory expectations. Our objective is to help you achieve audit readiness while minimizing disruption to your business operations.
What is the Medical Device Single Audit Program (MDSAP)?
The Medical Device Single Audit Program (MDSAP) is an international audit program that enables a recognized Auditing Organization to perform a single regulatory audit of a medical device manufacturer’s quality management system. The audit is designed to satisfy the requirements of multiple participating regulatory authorities through one harmonized assessment process.
The program is built around ISO 13485 requirements and incorporates country-specific regulatory requirements of participating authorities. Upon successful completion of the audit and closure of identified issues, the manufacturer receives an MDSAP audit report and certificate from the recognized Auditing Organization.
The MDSAP approach helps manufacturers demonstrate regulatory compliance while reducing the need for multiple independent audits across different markets.
MDSAP Participating Countries
Participating Regulatory Authorities:
- United States Food and Drug Administration (FDA)
- Health Canada
- Australia's Therapeutic Goods Administration (TGA)
- Brazil's National Health Surveillance Agency (ANVISA)
- Japan's Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA)
Why is MDSAP Important?
Key Benefits:
- One audit process accepted by multiple participating markets
- Reduced duplication of regulatory audits and inspections
- More efficient use of internal resources and audit preparation efforts
- Improved consistency in quality management system assessments
- Greater confidence in global regulatory compliance strategies
MDSAP Services You Can Rely On
MDSAP Gap Assessment
We assess your existing quality management system against MDSAP requirements and identify gaps that may impact audit readiness.
Quality Management System Review
Our team evaluates processes and documentation against ISO 13485 and applicable country-specific requirements included within the MDSAP framework.
Documentation Readiness Support
We help organize and review procedures, records, and supporting documentation required during the MDSAP audit process.
Audit Preparation Support
We provide structured guidance to prepare your organization, personnel, and quality systems for an MDSAP assessment.
Nonconformity Remediation Support
We assist in addressing identified nonconformities and implementing corrective actions to strengthen compliance.
Ongoing Compliance Support
Our team provides continued guidance to help maintain quality system effectiveness and readiness for future surveillance activities.
Who Needs MDSAP Services?
- Medical device manufacturers operating in multiple countries
- Organizations seeking access to participating regulatory markets
- Companies implementing or maintaining ISO 13485 quality management systems
- Manufacturers preparing for their first MDSAP audit
- Businesses seeking to reduce regulatory audit duplication
Why Choose Cert3Global?
- End-to-end MDSAP support
- Quality management system expertise
- Gap assessment and audit preparation guidance
- Documentation review and remediation support
- Practical regulatory advice focused on business objectives
- Ongoing compliance assistance
Prepare for MDSAP with Confidence!
The Medical Device Single Audit Program can simplify regulatory compliance and support international market access, but successful participation requires careful preparation and strong quality systems.
Cert3Global helps manufacturers navigate MDSAP requirements with practical guidance, structured preparation, and compliance-focused support.