Menu
Solutions

MDSAP - Quality Management System in the Medical Device Industry

Ensure regulatory compliance of your quality management system in 5 jurisdictions in one step - within one single audit.

Ensuring Quality and Safety in the
Medical Device Industry - MDSAP

The Medical Device Single Audit Program (MDSAP) is an international initiative that allows a single regulatory audit of a medical device manufacturer’s quality management system (QMS) to satisfy the requirements of multiple regulatory authorities.

Participating Regulatory Authorities:

  1. United States – FDA

  2. Canada – Health Canada (mandatory for Class II and above)

  3. Australia – Therapeutic Goods Administration (TGA)

  4. Brazil – ANVISA

  5. Japan – MHLW/PMDA

Key benefits of
MDSAP

Streamlined Global Compliance

Single audit satisfies multiple regulators, reducing redundancy and minimizing oversight burdens across global markets worldwide.

Faster Market Access

Harmonized requirements accelerate approvals, enabling quicker product launches and improving competitiveness in regulated regions globally.

Enhanced Quality Management

Comprehensive oversight strengthens QMS performance, improving consistency, reducing defects, and promoting continuous improvement culture industrywide.

Reduced Audit Disruptions

Coordinated audit reduces frequency, limiting operational interruptions and allowing teams to focus on innovation efforts; mandatory for Canada: Health Canada requires MDSAP certification for Class II–IV devices.

Increased Regulatory Confidence

Standardized assessment builds regulator trust, demonstrating compliance robustness and facilitating smoother interactions during reviews globally.


How to establish the quality management system according to the MDSAP?
Implementing the Medical Device Single Audit Program (MDSAP) involves a structured approach to ensure compliance with multiple regulatory jurisdictions through a single audit. The key steps for a successful MDSAP implementation:

  • How to establish the quality management system according to the MDSAP?
    Implementing the Medical Device Single Audit Program (MDSAP) involves a structured approach to ensure compliance with multiple regulatory jurisdictions through a single audit. The key steps for a successful MDSAP implementation:

    1. Understand the MDSAP Requirements
    2. Conduct a Gap Assessment
    3. Update and Align the QMS
    4. Train Key Personnel
    5. Conduct Internal Audits and Mock Audits
    6. Engage an MDSAP Recognized Auditing Organization
    7. Undergo the MDSAP Audit

Tadej Borštnar

Already established and certified management systems are my guarantee for your success

Contact Linkedin