ISO 14971 - Consulting & Implementation for Medical Device Risk Management (SaMD/MDSW)
Integrated Risk Management for Safe and Compliant Medical Device Software
Ensure regulatory compliance and patient safety with a clear, actionable, and compliant ISO 14971 risk management system. At QMLogic, we provide expert ISO 14971 consulting services that integrate seamlessly with your medical software development process (SaMD/MDSW) and broader medical device lifecycle.
From risk analysis to risk control and post-market monitoring, our approach connects ISO 14971 risk management to design controls, verification activities, and technical documentation, ensuring your product is market-ready for CE Marking (EU MDR 2017/745), FDA 510(k), and global MDSAP certifications.
Why Choose QMLogic for ISO 14971 Risk Management Consulting?
- Comprehensive Risk Management ExpertiseOur consultants apply real-world experience in risk-based design and regulatory submissions across FDA, EU MDR, and global markets.
- Full Integration with Your QMSWe ensure your risk management system integrates with your Quality Management System (ISO 13485) and product development documentation.
- Practical Training in Risk Assessment MethodsTraining tailored to your team’s needs, covering essential risk management tools like PHA, FMEA/DFMEA, or Fault Tree Analysis.
- Support for Digital Risk Management ToolsLeverage risk management automation and digitalization tools to streamline compliance and reduce manual effort.
Our ISO 14971 Risk Management Consulting Services
ISO 14971 Risk Management System Implementation
We help you build and implement an ISO 14971-compliant risk management system, including:
- Risk Management Planning
- Preliminary Hazard Analysis (PHA)
- Design Failure Mode and Effects Analysis (DFMEA)
- Risk Evaluation
- Risk Control
- Verification of Risk Control Measures
- Production and Post-Market Surveillance Activities
ISO 14971 Certification Support
Prepare for CE marking and FDA approval with complete documentation:
- Risk Management File (RMF)
- Traceability Matrices (from hazards to controls)
- Documentation review for ISO 14971 certification
Integrated Risk Management and Digitalization Tools
We help you integrate risk management activities into your digital quality system:
- Digital Risk Management File Solutions
- Automated Traceability & Updates
- Risk Data Visualization Dashboards
- CI/CD and Agile Development Integration
Learn more about QM Automation & Digitalization
See moreAdditional Regulatory Consulting Services
Our ISO 14971 consulting complements:
ISO 13485 Quality Management Systems Implementation
See moreIEC 62304 Software Lifecycle Processes
See moreTechnical Documentation and CE/FDA Submissions Preparation
See moreIEC 81001-5-1 Health Software and IT Systems Security
See moreWhat risk assessment techniques are commonly used?
- Preliminary Hazard Analysis (PHA)
- Design Failure Mode and Effects Analysis (DFMEA/FMEA)
- Fault Tree Analysis (FTA)
- Hazard and Operability Study (HAZOP)
We train your team in the proper use of these risk management tools to ensure regulatory acceptance.