IEC 62304
Medical Device Software Life Cycle Processes
IEC 62304 defines a software lifecycle for medical-device software. It covers planning, requirements, architecture, implementation, verification, maintenance, problem resolution, and risk-control traceability.
Use it when software contributes to a medical device or supports a safety-relevant medical function. The standard classifies software safety classes and expects disciplined evidence tied to device risk management.
CSA helps map the lifecycle, review software safety classification, build traceability and verification evidence, support certification preparation, train teams, and staff safety-critical software roles.
Quick facts
The certification path CSA runs for IEC 62304
How CSA helps with IEC 62304
View servicesAssessment
Gap reviews, safety lifecycle audits, evidence checks, and assessment readiness.
View servicesCertification support
Safety plans, safety cases, traceability, verification evidence, and assessor response support.
View servicesTraining
Private workshops and standard-specific training for engineering, product, and leadership teams.
View servicesStaffing
Contract, direct-hire, embedded, and fractional safety leaders matched by standard and domain.
View servicesCompanies working to this standard
281 companies in the All Companies directory are mapped to IEC 62304 by the generated company data.
Related standards
Services for IEC 62304
View all servicesRisk Assessment
A complete ISO 12100 or sector-appropriate risk assessment with one stakeholder review cycle, producing the documented basis for your safety concept.
View serviceFunctional Safety Gap Analysis & Roadmap
Structured assessment of your current safety lifecycle and evidence against target standards, delivering a certification roadmap with effort estimates.
View serviceProduct Certification Management
A CSA safety manager runs your certification program end to end: planning, evidence management, assessor liaison, and closure.
View serviceNot sure how IEC 62304 applies to your product?
A call with a CSA engineer will map the standard to your product and market in plain language.