Auditing and Mock Inspection Services MDSAP and ISO Auditing Services

Navigate global medical device requirements with integrated audits that satisfy multiple regulators, streamline compliance efforts, and open worldwide market access.

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One audit, five countries, endless opportunities for compliance efficiency

The Medical Device Single Audit Program (MDSAP) streamlines global compliance by allowing one audit to satisfy five major regulators—FDA, Health Canada, Brazil's ANVISA, Japan's MHLW/PMDA, and Australia's TGA. Combined with ISO 13485:2016 certification, MDSAP provides comprehensive evidence of quality system compliance for worldwide market access.

But MDSAP audits demand more than traditional ISO assessments. Auditors must understand each country's specific requirements, regulatory differences, and reporting expectations. The audit scope expands to cover country-specific elements while maintaining the systematic approach regulators expect.

Our MDSAP and ISO auditors are qualified by recognized certification bodies and experienced in multi-country requirements. We help you prepare for successful certification while building systems that satisfy global expectations.

 

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Our MDSAP & ISO audit services include:

  • Gap assessments against MDSAP and ISO requirements
  • Country-specific requirement analysis
  • Quality system documentation review
  • Management process evaluation
  • Device realization assessment
  • Measurement and improvement systems
  • Medical device reporting procedures
  • Distribution and service controls
  • Purchasing and supplier management
  • Risk management integration
  • Software validation approaches
  • Post-market surveillance systems
  • Internal audit program effectiveness

Key differences we address:

  • FDA quality system regulation alignment
  • Health Canada licensing requirements
  • Brazil GMP specific elements
  • Japan ministerial ordinances
  • Australia therapeutic goods orders
  • ISO 13485:2016 harmonization

Click to expand MDSAP and ISO regulations and standards we audit against

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We help clients align their quality systems with global requirements—evaluating compliance across international standards, national regulations, and region-specific expectations. Below is a breakdown of the primary frameworks and regulatory requirements our MDSAP and ISO audit services address. This is not an exhaustive list. Please talk to us for more details.

International Standards

  • ISO 13485:2016 Quality management systems for medical devices. Audited in all MDSAP jurisdictions. Forms the foundation for quality system certification and regulatory alignment. Also relevant for the upcoming transition from the QSR to the QMSR in 2026.

  • ISO 14971:2019 Risk management standard for medical devices. Often evaluated alongside ISO 13485 and required by multiple regulators.

Country-Specific Regulations Covered by MDSAP

  • United States (FDA)

    • 21 CFR Part 820 – Quality System Regulation (QSR)

    • 21 CFR Part 803 – Medical Device Reporting

    • 21 CFR Part 806 – Reports of Corrections and Removals

    • 21 CFR Part 807 – Establishment Registration and Device Listing

    • FDA's new Quality Management System Regulation (QMSR) alignment with ISO 13485

  • Canada (Health Canada)

    • Medical Devices Regulations (SOR/98-282)

    • Licensing and mandatory problem reporting requirements

    • Emphasis on ISO 13485:2016 compliance via MDSAP participation

  • Brazil (ANVISA)

    • RDC No. 665/2022 – Brazilian Good Manufacturing Practices (BGMP)

    • RDC No. 751/2022 – Risk classification and regularization

    • Additional documentation, language, and legal representation requirements

  • Japan (MHLW/PMDA)

    • Ministerial Ordinance No. 169 – Quality Management System requirements

    • GVP Ordinance – Good Vigilance Practices

    • GCP Ordinance – Good Clinical Practices (when applicable)

  • Australia (TGA)

    • Therapeutic Goods (Medical Devices) Regulations

    • TGA Conformity Assessment Procedures

    • Essential Principles aligned with ISO 13485 and risk-based classification

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The FDA Group's MDSAP and ISO audit advantages

  • MDSAP qualified: Auditors meet program requirements.
  • Multi-country expertise: Understand all participating regulators.
  • Practical focus: Build systems that work globally.
  • Certification support: Guide through successful audits.

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VEEVA AUDIT MANAGEMENT SUPPORT Veeva eQMS data entry services

Is your team using Veeva as your eQMS? In addition to conducting audits, we can complete your data entry directly within your Veeva system, saving you significant time and attention.

Our dedicated project support team works directly with our auditors to streamline the process of inputting audit reports into the Veeva platform. We’ll guide your Veeva Administrator through the steps to confer the necessary user permissions in the platform and take care of the audit input on your behalf. 

Contact us to learn more about integrating Veeva management into your auditing service so you can focus on your core operations.

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Why work with The FDA Group?

 
  • Exclusive life science focus and expertise
  • Dedicated account management team
  • Right resource, first time (95% success)
  • 97% client satisfaction
  • Total Quality Guarantee

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Contact us today to learn more about our MDSAP and ISO audit services.