Quality Management System Implementation Services
Overview of MDSAP
The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single regulatory audit that satisfies the requirements of multiple jurisdictions, including the United States (FDA), Canada (Health Canada), European Union (for auditing purposes), Japan (PMDA/MHLW), Brazil (ANVISA), and Australia (TGA).
MDSAP reduces duplication, saves time, and provides a harmonized approach to compliance across major global markets. Sterling Medical Registration guides you through MDSAP readiness, audit preparation, and ongoing system maintenance, ensuring your QMS meets the expectations of all participating authorities.
This overview positions your QMS services as globally comprehensive and highlights the added value of MDSAP for international manufacturers.
Comparison of Global Medical Device QMS Frameworks
Framework | Scope & Focus | Key Requirements | Market Coverage |
EU MDR 2017/745 | European Union medical device regulation | Technical documentation, clinical evaluation, PMS, vigilance, QMS aligned with ISO 13485 | Mandatory for CE marking in the EU |
ISO 13485:2016 | International QMS standard for medical devices | Quality Management System(QMS), management responsibility, resource management, product realization, measurement, analysis, and improvement. Risk management - risk based approach, process interaction, regulatory compliance. | Recognized globally as the baseline QMS standard |
FDA QMSR (21 CFR Part 820) | U.S. FDA Quality Management System Regulation | Similar to ISO 13485, but with specific requirements tailored to the U.S. market such as Unique Device Identification (UDI), complaint handling, and regulatory reporting. | Required for U.S. market clearance and inspections |
Canada (SOR/98-282) | Canadian Medical Device Regulations | QMS certification to ISO 13485, licensing, post‑market obligations | Required for medical device licensing in Canada |
MDSAP (Medical Device Single Audit Program) | Harmonized audit program across multiple regulators | One audit covering ISO 13485 plus country‑specific requirements | Accepted by FDA (U.S.), Health Canada, Brazil (ANVISA), Japan (PMDA/MHLW), Australia (TGA) |
Overview of MDSAP
The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single audit that satisfies multiple regulatory authorities simultaneously. It integrates ISO 13485 with country‑specific requirements, reducing duplication and streamlining compliance. Participating regulators include the U.S. FDA, Health Canada, Brazil’s ANVISA, Japan’s PMDA/MHLW, and Australia’s TGA.
Sterling Medical Registration helps organizations prepare for and succeed in MDSAP audits, ensuring their QMS is globally compliant and audit‑ready.