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 Expertise
Our consultants apply real-world experience in risk-based design and regulatory submissions across FDA, EU MDR, and global markets.
Full Integration with Your QMS
We ensure your risk management system integrates with your Quality Management System (ISO 13485) and product development documentation.
Practical Training in Risk Assessment Methods
Training tailored to your team’s needs, covering essential risk management tools like PHA, FMEA/DFMEA, or Fault Tree Analysis.
Support for Digital Risk Management Tools
Leverage 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:
Vaclav and I worked together on risk management activities of medical device development projects. His ability to quickly grasp the challenges and to accomplish a task/project is remarkable. Additionally, his ability to propose and develop software solutions to improve projects’ efficiency is commendable. I find Vaclav to be flexible, dependable, and quality centric. Hence, I really enjoyed working with Vaclav and looking forward to associate with him again.
I had the pleasure to work with Vaclav during our development of a medical product for Merck. I found Vaclav to be very professional and devoted. His attention to detail and his technical /medical knowledge brought immense valuable inputs to the project. Collaborate with Vaclav was really a pleasure and I warmly recommend him.
Bei Ypsomed hat Vaclav in meinem Risk Management Team einen wertvollen Beitrag geleistet und unsere Arbeiten vorangebracht. Seine umfassende Expertise haben wir im Team sehr geschätzt. Die ihm zugewiesenen Arbeiten hat er selbstständig und zu unserer vollen Zufriedenheit erledigt. Besonders erwähnen möchte ich, dass er zu vorhandenen Problemstellungen im Risk Management kreative Lösungsvorschläge aufgrund seiner Erfahrung in der Software Programmierung einbringen konnte. Die Zusammenarbeit mit Vaclav war sehr angenehm. Ich möchte mich bei Vaclav für die tolle Zeit und die geleistete Arbeit bedanken. Vaclav kann daher nur weiterempfehlen.
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