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The Comprehensive Handbook on Efficient IEC 62304 Compliance
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What is IEC 62304, and why it's important?
IEC 62304 is an internationally harmonized standard for medical device software lifecycle processes, recognized by FDA and other regulatory agencies across the world. IEC 62304 provides guidance to the manufacturer on planning, development, and postmarket surveillance activities for medical device software to ensure companies are in compliance with both U.S. and other international regulatory requirements.
Based on the device risk classification, IEC 62304 provides guidance for risk control measures that must occur throughout the life cycle of that particular device.
- What is the importance of IEC and Medtech Compliance Standards
- How to ITEM templates simplify your IEC 62304 compliance process.
- How to Apply IEC 62304 Requirements for Medical Device Software
- How to establish traceability to accelerate IEC 62304 compliance
- Efficiently achieve ongoing IEC 62304 compliance
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