We provide compliance consulting under the IEC 62304 standard for medical device software development and lifecycle management.
IEC 62304 is the foundational international standard that defines requirements for the development, maintenance, and risk management of medical device software. Referenced by regulatory bodies such as the FDA, CE, and MDR for software compliance processes, the standard classifies software into safety classes (Class A, B, C) — each subject to different development and validation obligations.
TUGAY provides comprehensive consulting to medical software manufacturers on process design, risk management, and technical file preparation that meets IEC 62304 requirements.
Request ConsultingIEC 62304 divides software into three classes based on the risk level if the software fails.
Software whose failure cannot cause injury or death. Basic documentation and process management are sufficient.
Software whose failure could cause serious injury. Requires comprehensive testing and verification activities.
Software whose failure could cause death or irreversible serious injury. The most comprehensive compliance obligations.
We determine the safety class of your medical device software and its associated compliance obligations, then build a roadmap.
We document the software development, verification, and maintenance processes mandated by IEC 62304.
We design an integrated risk management process with ISO 14971 and complete software-specific risk analysis.
We prepare technical file content for regulatory submissions under FDA 510(k), CE marking, or MDR.
We create unit, integration, and system test plans in compliance with IEC 62304 requirements.
We conduct internal assessments and gap analyses in preparation for notified body or FDA audits.
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Assessment scope