Standards
Compliance standards, explained
The standards that govern medical and automotive electronics decide how a product is designed, verified, and documented. Here is what each one requires, who needs it, and how it shapes development — in plain English from engineers who design to them.
IEC 62304
Medical
Medical Device Software Lifecycle
IEC 62304 is the international standard for the software development lifecycle of medical device software, scaled to safety class A, B, or C.
Read explainerISO 13485
Medical
Medical Device Quality Management System
ISO 13485 is the international standard for a quality management system (QMS) for organizations that design, develop, and manufacture medical devices.
Read explainerISO 26262
Automotive
Automotive Functional Safety
ISO 26262 is the functional-safety standard for electrical/electronic systems in road vehicles, managing failure risk via ASIL levels A-D.
Read explainerIEC 60601-1
Medical
Medical Electrical Equipment Safety
IEC 60601-1 is the foundational safety standard for medical electrical equipment, covering electrical, mechanical, and thermal hazards to patients and operators.
Read explainerNeed a product verified and documented against one of these standards? Explore compliance testing services