Medical device manufacturers seeking access to global markets often encounter complex regulatory requirements. Two widely recognized frameworks—MDSAP (Medical Device Single Audit Program) and ISO 13485—play a crucial role in demonstrating compliance with quality management system standards. While both aim to ensure the safety and effectiveness of medical devices, they are not the same. Understanding the key differences between MDSAP and ISO 13485 can help manufacturers choose the right pathway for compliance, market access, and regulatory success.
In this blog, we’ll break down the difference between MDSAP and ISO 13485, their benefits, global acceptance, audit process, and how medical device companies in the USA can leverage both to strengthen their regulatory strategies.
What is ISO 13485?
ISO 13485 is an internationally recognized standard that outlines the quality management system (QMS) requirements for medical device manufacturers. It is designed to ensure organizations consistently produce safe and effective devices that meet both customer and regulatory requirements.
Key Features of ISO 13485:
- Focuses on QMS processes specific to the medical device industry.
- Emphasizes risk management, design control, documented procedures, and regulatory compliance.
- Applicable to all stages: design, development, production, storage, distribution, installation, and servicing.
- Recognized globally, including by regulators in the EU, Canada, Australia, Japan, and the USA.
ISO 13485 certification is often a prerequisite for market entry, particularly for obtaining CE Marking in Europe or participating in the FDA 510(k) process.
What is MDSAP?
The Medical Device Single Audit Program (MDSAP) allows manufacturers to undergo a single regulatory audit to satisfy the requirements of multiple countries. MDSAP was developed by the International Medical Device Regulators Forum (IMDRF) to streamline and harmonize global audits.
Participating Countries:
- United States (FDA)
- Canada (Health Canada)
- Brazil (ANVISA)
- Australia (TGA)
- Japan (PMDA/MHLW)
Key Features of MDSAP:
- One audit = compliance with multiple regulatory jurisdictions.
- Audits conducted by authorized Auditing Organizations (AOs).
- Covers country-specific requirements in addition to ISO 13485.
- Mandatory for Canada: Health Canada requires MDSAP certification for all medical devices sold in Canada.
MDSAP vs. ISO 13485: Key Differences
| Feature | ISO 13485 | MDSAP |
|---|---|---|
| Purpose | Establishes a QMS framework for medical devices | Verifies compliance with regulatory requirements of multiple countries |
| Scope | International QMS standard | Multi-country regulatory compliance program |
| Audit Body | Certification Bodies (CBs) | MDSAP-recognized Auditing Organizations (AOs) |
| Recognized By | Global regulatory agencies (EU, US, etc.) | US, Canada, Australia, Brazil, Japan |
| Mandatory? | Voluntary but required for many markets | Mandatory for Canada; optional elsewhere |
| Covers ISO 13485? | Yes | Yes, plus additional country-specific requirements |
| Audit Duration | Generally shorter | More comprehensive, time-intensive |
Why Choose ISO 13485 Certification?
Global Market Access
ISO 13485 certification is often required for medical device approvals in the European Union, UK, and several other countries.
Improved Quality Management
It helps streamline internal processes, enhance product quality, and minimize risks.
Foundation for Other Certifications:
It forms the core of the MDSAP audit. Achieving ISO 13485 first can simplify the MDSAP process later.
Why Choose MDSAP Certification?
Multi-Country Compliance
MDSAP provides a cost-effective, unified audit process covering regulatory compliance in five major markets.
FDA Recognition
The U.S. FDA accepts MDSAP audit reports in place of routine inspections.
Essential for Canadian Market
Health Canada mandates MDSAP certification for all licensed medical devices.
Can You Have Both ISO 13485 and MDSAP?
Yes, absolutely. In fact, MDSAP audits are based on ISO 13485:2016, with added regulatory requirements specific to each participating country. Many manufacturers first obtain ISO 13485 certification, then upgrade to MDSAP for broader compliance.
How Can USA-Based Companies Prepare?
If you’re a medical device manufacturer in the USA, here’s how to strategically approach compliance:
- Evaluate Target Markets: If your business is planning to enter Canada, MDSAP is mandatory. If you’re targeting the EU, ISO 13485 is essential for CE marking.
- Assess Current QMS Maturity: Start with an internal gap assessment to determine whether your current system aligns with ISO 13485 and MDSAP requirements.
- Work with Regulatory Consultants: An experienced MDSAP or ISO 13485 consultant can guide you through documentation, audit preparation, and implementation—saving time, reducing errors, and improving audit outcomes.
- Leverage Turnkey Compliance Services: Partnering with consultants who offer turnkey QMS setup, audit readiness, and post-certification support can ensure faster certification and smoother market entry.
Need Help with MDSAP or ISO 13485 Compliance?
At Operon Strategist, we specialize in MDSAP consulting, ISO 13485 certification support, and turnkey QMS implementation for USA-based medical device companies. Whether you’re a startup or an established manufacturer, our experts can help you achieve compliance and accelerate market access.
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