ISO 14971 is the international standard for risk management in medical devices across the entire lifecycle. It's required for device approval at the Ministry of Health (AMR), CE Mark and FDA, and complements ISO 13485. CBE guides you through the entire process.
CBE specializes in guiding and certifying organizations for the ISO 14971 standard, tailoring the management system to the organization's needs.
Quick facts – ISO 14971
Goal
Systematic risk management across the device's life
Who needs it
Medical-device makers, medical software, IVD
Importance in Israel
Required for AMR, CE Mark and FDA approval
Complements
ISO 13485, IEC 62304, ISO 27799
CBE – success rate
100% – hundreds of guided clients
ISO 14971 is the leading international standard for risk management in medical devices. It defines a systematic process for identifying, assessing, controlling and monitoring risks across the entire lifecycle of the device — from design to end-of-use.
The standard is based on the 'As Low As Reasonably Practicable' (ALARP) principle and a proven risk-management approach, and integrates with MDR (EU) and FDA requirements for risk management in medical devices.
In Israel ISO 14971 is required as part of the medical-device approval process at the Ministry of Health (Medical Devices Department — AMR), and for CE Mark and FDA. It complements ISO 13485 and forms the basis for IEC 62304 for medical software.
Mapping possible risks to the patient, operator and third parties across the device's life.
Assessing risk severity and choosing controls to reduce it to an acceptable level.
Monitoring risks after marketing too — complaints, events and updates.
Documenting the risk-management process — a complete Risk File.
Required for AMR, CE Mark (MDR) and FDA approval — mandatory for every device.
To sector pageIn-vitro diagnostic devices — risk management across the device's life.
To sector pageSoftware as a medical device — risk management per ISO 14971 before IEC 62304.
To sector pageMedical startups — required for regulatory approval and for investors.
To sector pageDevice manufacturers — risk management in the production process and design.
To sector pageCE Mark (MDR) and FDA — both require risk management per ISO 14971.
A threshold condition for AMR, CE Mark (MDR) and FDA approval
A systematic framework that reduces risks to the patient, operator and third parties
Forms the basis for the quality system and for IEC 62304 for medical software
Orderly risk-management documentation strengthens investor and partner trust
Defining the organization's needs, stakeholders and the scope of the quality management system.
Process planning and control, managing customer requirements, external providers and output control.
Management commitment, quality policy and defining roles and responsibilities.
Measurement, analysis, internal audit and management review.
Risk and opportunity management, quality objectives and plans to achieve them.
Managing non-conformities, corrective actions and continuous improvement of the system.
Resources, employee competence, internal communication and documentation.
CBE performs a full Gap Analysis and builds a work plan tailored to your organization.
ISO 14971 is part of a full medical framework — CBE guides you through all of it
CBE accompanies you at every stage — from mapping risks to the complete Risk File
Defining policy, criteria and responsibilities for the risk-management process
Mapping possible risks across the device's life (FMEA, FTA)
Assessing severity and probability, choosing controls and reducing risk
Full documentation of all decisions and controls — the Risk File
Post-market monitoring: complaints, events and risk updates
30 years, hundreds of clients, 100% success — here's what sets us apart
Committed to success! Professional guidance that leads to a complete, approved Risk File.
Rich experience with medical devices, IVD and SaMD.
CBE's skilled human team writes your Risk File and documentation tailored to your device.
ISO 14971, ISO 13485, IEC 62304, ISO 27799 — under one roof.
Familiarity with AMR, MDR (EU) and FDA risk-management requirements.
From startup to corporation — experience with every organization type in every field.
ISO 14971 is the risk-management foundation — but medical devices require a full regulatory framework. CBE builds an integrated compliance plan with all the medical standards.
About CBE's GRC frameworkCBE specializes in guiding and certifying organizations for the ISO 14971 standard. The service is provided by CBE's experts, with 30 years of experience in ISO standards, over 4,000 satisfied clients and 100% success in audits.
Tell us about your device and your approval target (AMR / CE / FDA) — we'll build a risk-management plan