IEC 62304 is the international standard for the software lifecycle in medical devices (including SaMD). It's required for approving medical devices that include software at the Ministry of Health, CE Mark (MDR) and FDA. It complements ISO 13485 and ISO 14971. CBE guides you through the entire process.
CBE specializes in guiding and certifying organizations for the IEC 62304 standard, tailoring the management system to the organization's needs.
Quick facts – IEC 62304
Goal
An orderly software lifecycle in medical devices
Who needs it
Medical-software developers, SaMD, devices with software
Importance in Israel
Required for AMR, CE Mark and FDA for software
Complements
ISO 13485, ISO 14971, ISO 27799
CBE – success rate
100% – hundreds of guided clients
IEC 62304 is the international standard for software lifecycle processes in medical devices. It defines requirements for development, maintenance, risk management, testing and change management — by the software's risk level (Class A/B/C).
The standard applies to software that's part of a medical device or is itself a medical device (SaMD — Software as a Medical Device), and integrates with MDR (EU) and FDA requirements.
In Israel IEC 62304 is required for approving medical devices that include software at the Ministry of Health (AMR), and for CE Mark and FDA. It relies on risk management per ISO 14971 and on the ISO 13485 quality system.
Planning, development, testing, release, maintenance and change management.
Division by the software's impact on patient safety.
Verification, validation and testing requirements by risk level.
An orderly process for changes, updates and maintenance across the software's life.
Apps and software that are themselves a medical device — IEC 62304 is required.
To sector pageMedical devices with embedded software — required for regulatory approval.
To sector pageMDR (EU) and FDA require a software lifecycle per IEC 62304.
A threshold condition for AMR, CE Mark (MDR) and FDA for medical software
A systematic framework for developing patient-safe software
Relies on risk management and integrates with ISO 13485
Orderly lifecycle 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.
IEC 62304 is part of a full medical framework — CBE guides you through all of it
CBE accompanies you at every stage — from risk classification to lifecycle documentation
Determining the software's risk level (Class A/B/C) with ISO 14971
A development plan, architecture, requirements and software spec
Implementation, unit testing, integration and verification by risk level
Full lifecycle documentation, version release and validation
Change management, updates and maintenance across the software's life
30 years, hundreds of clients, 100% success — here's what sets us apart
Committed to success! Professional guidance that leads to complete lifecycle documentation.
Experience with SaMD, embedded software and medical AI.
CBE's skilled human team writes your lifecycle documentation tailored to your software.
IEC 62304, ISO 14971, ISO 13485, ISO 27799 — under one roof.
Familiarity with AMR, MDR (EU) and FDA requirements for medical software.
From startup to corporation — experience with every organization type in every field.
IEC 62304 is the software lifecycle standard — but it relies on risk management and a quality system. CBE builds an integrated compliance plan for all the medical standards.
About CBE's GRC frameworkCBE specializes in guiding and certifying organizations for the IEC 62304 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 software and your approval target — we'll build a lifecycle plan per IEC 62304