QMS Consultancy Services

A strong, compliant Quality Management System (QMS) is the backbone of safe, reliable, and globally accepted medical devices. Masuu Global Solutions provides comprehensive QMS consultancy services that help manufacturers design, implement, maintain, and optimize QMS frameworks aligned with major global regulatory requirements.

Our services ensure that your organization consistently meets quality expectations, regulatory obligations, and market‑specific compliance standards across the entire device lifecycle.

Global QMS Standards We Support

Masuu helps manufacturers achieve compliance with all major international QMS frameworks, including:
  • ISO 13485:2016 – Global medical device QMS standard
  • US FDA 21 CFR Part 820 / QMSR – U.S. Quality System Regulation
  • MDSAP (Medical Device Single Audit Program) – Multi‑country audit model
  • KGMP – Korea Good Manufacturing Practice
  • BGMP – Brazil Good Manufacturing Practice
  • Indian MDR 2017 – India medical device regulations
  • QSD (Quality System Documentation) – Taiwan regulatory requirement
  • Japan MHLW MO169 – Japanese QMS standard
These frameworks ensure device safety, regulatory consistency, and readiness for inspections across global markets.

Our Core QMS Services

  1. QMS Design & Implementation
    2. We build compliant, scalable, and audit‑ready QMS frameworks tailored to your device category, company structure, and target markets.
  1. Regulatory Compliance Support
    2. End‑to‑end assistance to help you meet the expectations of EU, US, APAC, LATAM, and Middle East regulatory authorities.
  1. Audit & Gap Assessments
    • Internal and supplier audit support
    • Gap analysis against ISO 13485, FDA QMSR, MDR, IVDR, and MDSAP requirements
    • Actionable remediation plans to address findings
  1. Risk Management
    2. End‑to‑end ISO 14971:2019 implementation, including:
    • Risk file creation
    • Hazard analysis
    • Benefit–risk evaluation
    • Post‑market risk updates
  1. Training & Education
    2. Customized training programs to upskill your teams in QMS implementation, compliance, audit readiness, documentation, and risk management.

Masuu’s QMS Consultancy Service Portfolio

ISO 13485 Certification Support

We guide you through every stage—gap analysis, documentation, implementation, internal audits, and certification readiness.

MDSAP Readiness & Support

Assistance with MDSAP audit preparation, documentation updates, and remediation for Canada, Australia, Brazil, the U.S., and Japan.

FDA 21 CFR Part 820 / QMSR Compliance

Support for implementing and maintaining U.S. FDA QMS requirements, including upcoming QMSR alignment with ISO 13485.

ISO 14971 Risk Management Consulting

Full lifecycle risk management services to integrate risk control measures into all QMS and technical documentation.

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