Development plan and safety classification
Define responsibilities, outputs, review and test milestones and safety class rationale.
Medical & healthcare
Make software lifecycle activities and evidence traceable
IEC 62304 covers lifecycle processes for standalone and embedded medical device software. Connect planning, requirements, architecture, verification and maintenance to the product's risk management.
Source record updated:
Discuss your certification →Scope and applicability
Medical device software development and maintenance lifecycle standard
It is not a standalone Korean product authorization. Confirm the edition and evidence level for the target market and assessor, and manage final device validation and release requirements separately.
Korean certification schemes and international standards are different. A translated guide does not extend a Korean certificate to other countries. Confirm the target market, product classification and current requirements with the relevant body.
Who this is for
- Standalone medical software developers
- Embedded medical device software teams
- Teams preparing lifecycle evidence for regulatory submissions
Documents to prepare
Requirements, design and verification traceability
Connect requirements and design to unit, integration and system tests and unresolved issue decisions.
Configuration, problem resolution and maintenance
Link versions, third-party software, defects and change impact to risk management.
Preparation process
Review the development system
Identify scope, edition, safety class, available outputs and missing activities.
Complete verification and traceability
Plan tests including risk controls and link results, issues and retesting.
Establish release and change controls
Review acceptance criteria and remaining issues and operate post-release defect, security and update procedures.
Timing
Software size, safety class and record completeness affect effort. Repeating tests or reconstructing requirements takes longer than organizing documents.
Agency fees
Standards-related assessment and testing
Separate quotation
No single Korean statutory certification fee is established by this standard's name alone. Confirm standard purchase, testing, assessment and product authorization costs separately.
Sources and references ↗Document automation and management cost KRW 300,000 per month. Expert services and certification body testing or assessment fees are separate. Specify supports preparation; the relevant authority or certification body makes the final decision.
Pricing and certification costs →Optional expert consulting
Expert review and consulting are optional, separately scoped services. Choose support for IEC 62304 based on your team's readiness and the evidence or assessment preparation you need.
- Confirm institutional testing, assessment and registration fees separately in the contract.
- Development fixes, clinical studies where applicable, security equipment and infrastructure operations may require separate budgets.
- Confirm internal staffing, travel, translation, VAT, surveillance and renewal costs in the quotation.
Questions and answers
Does an IEC 62304 certificate permit sales?
Conformity evidence or a private assessment does not automatically replace Korean product authorization and quality requirements.
Are unit test results sufficient?
Requirements, design, integration and system verification, risk and change records must also be connected.
Can open-source components be used?
The standard does not categorically exclude them. Identify components, versions, known problems, risk impact and management evidence.