ISO 14971 Risk Management Consulting

Managing risks throughout the lifecycle of a medical device is both a regulatory obligation and a critical component of patient safety. ISO 14971:2019 is the globally recognized standard for medical device risk management—and is accepted by regulators such as the U.S. FDA, Health Canada, TGA, PMDA, and EU authorities under MDR and IVDR.

Masuu Global Solutions simplifies ISO 14971 implementation for manufacturers of medical devices, IVDs, and SaMD, helping establish, maintain, and optimize compliant risk‑management systems. From hazard identification to post‑market monitoring, we guide you through a structured and internationally aligned framework to ensure safe, compliant, and globally market‑ready products.

ISO 14971 Risk Management Consulting – Overview

Managing device risks can quickly become complex—one oversight may lead to regulatory delays, safety issues, or costly redesigns. ISO 14971 requires manufacturers to implement a formal, documented, and auditable risk‑management system covering:

  • Risk analysis
  • Risk evaluation
  • Risk control
  • Benefit–risk assessment
  • Lifecycle monitoring and review
  • Post‑market data integration

Masuu helps organizations build and sustain an ISO 14971‑compliant process that integrates seamlessly with QMS requirements under ISO 13485, MDR/IVDR expectations, and global regulatory frameworks.

Our experts support you across planning, execution, gap closure, documentation, and ongoing maintenance—turning regulatory complexity into streamlined, confident compliance.

Masuu’s ISO 14971 Risk Management Services Include:

  1. Risk Management Process Development
  • Establishing a complete, compliant risk‑management framework
  • Integration with design controls, PMS, and CER/PER activities
  • Mapping risks to General Safety & Performance Requirements (GSPRs)
  1. Assignment of Qualified Personnel
  • Supporting manufacturers in defining roles and responsibilities
  • PRRC and SME involvement in high‑risk or specialized product categories
  1. Production & Post‑Production Monitoring Setup
  • Creating processes to collect and evaluate real‑world safety data
  • Vigilance, PMS, PMCF/PMPF, and trending integration
  • Updating risk files based on post‑market outcomes
  1. Gap Analysis & Remediation
  • Comparing existing procedures to ISO 14971:2019 requirements
  • Identifying deficiencies in methodology, documentation, or evidence
  • Creating remediation plans and corrective actions
  1. Complete Risk File Development
  • Hazard identification and characterization
  • Probability and severity assessments
  • FMEA/FMECA, Fault Tree, HHE integration
  • Residual risk evaluation and acceptance justification
  • Traceability to design, usability, and PMS outputs

Masuu’s ISO 14971 Consulting Expertise

  • Full-scope medical device risk‑management consulting
  • Migration support from ISO 14971:2007 → ISO 14971:2019
  • Comprehensive gap analysis and remediation plan creation
  • Development of lifecycle risk‑management procedures and templates
  • Support across critical areas such as:
    • Risk analysis
    • Benefit–risk evaluation
    • Post‑market risk updates
    • PMS/PMCF/PMPF integration

Advantages of Partnering with Masuu Global Solutions

  • Highly qualified risk‑management specialists with experience across device types and classifications
  • Expertise across QMS frameworks such as ISO 13485, MDSAP, and FDA QMSR
  • Deep understanding of technical and functional device attributes for 360‑degree risk coverage
  • Proven success delivering risk‑management systems for diverse product categories
  • Ability to support high‑risk, software‑driven, and AI‑enabled devices
  • End‑to‑end support from planning to implementation to post‑market monitoring
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