Quality Management System (QMS) Services for Medical Devices

A robust Quality Management System (QMS) is fundamental to ensuring the safety, reliability, and regulatory compliance of medical devices throughout their lifecycle—from concept and design to manufacturing, distribution, and post market monitoring. Compliance with global QMS standards such as ISO 13485:2016, FDA QMSR/21 CFR Part 820, MDSAP, KGMP, BGMP, Indian MDR 2017, Taiwan QSD, and Japan MHLW MO169 is essential for gaining and maintaining global market access.

Masuu Global Solutions provides comprehensive QMS services designed to meet region specific requirements, streamline processes, and ensure audit ready documentation across all product categories.

QMS Services for Medical Devices – Overview

A Quality Management System is a structured framework of processes, policies, tools, and procedures that ensures:
  • Devices are safe and effective
  • Products meet global regulatory and quality standards
  • Manufacturers maintain consistent performance across the full device lifecycle

Regulatory bodies worldwide require medical device manufacturers to adopt standards such as:

  • ISO 13485:2016 – Global QMS standard
  • FDA QMSR / 21 CFR Part 820 – U.S. Quality System Regulation
  • EU MDR 2017/745 – Technical & QMS expectations for medical devices
  • MDSAP – Multicountry QMS audit program
  • KGMP, BGMP, QSD, MO169, MDR 2017 India

These frameworks ensure that manufacturers maintain consistent compliance across markets.

Masuu’s QMS Service Portfolio

We support manufacturers across all major QMS components:

QMS Consultancy & Implementation

  • ISO 13485:2016 implementation
  • FDA QMSR/21 CFR 820 compliance
  • MDSAP readiness
  • KGMP, BGMP, Taiwan QSD, MO169 Japan, Indian MDR 2017 compliance

Risk Management – ISO 14971 Consulting

  • Risk file creation, updates, and lifecycle maintenance
  • Full alignment with PMS, CER/PER, PMCF/PMPF evidence

QMS Remediation

  • Upgrading outdated QMS elements
  • Addressing audit findings and NCs
  • Bringing legacy documentation up to modern regulatory standards

Audit & Compliance Support

  • Mock audits
  • Internal audits
  • Supplier audits
  • Audit readiness for NB, FDA, TGA, MFDS, NMPA, and more

QMS Toolkit Development

  • SOPs, Work Instructions (WIs), templates, manuals
  • Forms and regulatory submission formatting

Document Management

  • Creation, review, and structuring of QMS documents
  • Support for regulatory submission documents including technical files

CAPA Management

  • Corrective & Preventive Action process design
  • CAPA documentation, trending, and root cause methodology

Supplier Evaluation

  • Supplier audits
  • Initial and ongoing qualification
  • Risk based vendor management

QMS Across the Product Lifecycle

Phase 1: Concept

  • QMS planning
  • Market specific regulatory requirements identification

Phase 2: Planning

  • QMS document creation (SOPs, WIs, templates, manuals, policies)

Phase 3: Design

  • Design control procedures
  • Usability/human factors engineering
  • Risk management file development
  • Technical documentation workflows

Phase 4: Validation

  • SaMD validation
  • Internal/mock/supplier audit readiness
  • Manufacturing, packaging, sterilization, and software validation
  • Product validation & traceability

Phase 5: Launch

  • QMS training for stakeholders
  • Labeling and product information compliance
  • Customer communication workflows
  • Distribution & installation support

Phase 6: Post Market

  • PMS Plans, PMSRs, PSURs
  • PMCF/PMPF Plans & Reports
  • CAPA, NC management
  • Annual Product Quality Review (APQR)
  • Design changes, QMS change control
  • External audit support
  • Risk monitoring and trending
  • Stability monitoring, servicing, customer property management

QMS Services for All Device Categories

Masuu supports QMS implementation and maintenance for:
  • Medical Devices
  • In Vitro Diagnostic (IVD) Devices
  • Combination Products
  • Software as a Medical Device (SaMD)

Masuu Global Solutions – QMS Service Catalog

  • QMS Consultancy
  • ISO 14971 Risk Management
  • QMS Remediation
  • Compliance & Audit Support
  • QMS Toolkit Development
  • Document Management
  • CAPA Management
  • Supplier Evaluation

Benefits of Masuu’s QMS Services

  • Cost effective QMS solutions
  • Expert regulatory and quality specialists
  • Global partner network
  • Region specific QMS alignment
  • Standardized QA practices
  • Flexible staffing and resource augmentation

Additional Advantages

Although this section originally referenced 510(k) advantages, here is a corrected, Masuu aligned set of QMS specific advantages:
  • Proven experience supporting diverse medical device QMS implementations
  • Efficient handling of compliance documentation
  • Strong expertise in addressing regulatory queries and audit findings
  • Timely delivery and structured project execution
  • Upto date alignment with global QMS regulations and standards
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