- Whitepaper
The Comprehensive Handbook on Efficient IEC 62304 Compliance
Master international software lifecycle standards to ensure regulatory approval and streamline risk control across your device lifecycle.
Talk to Our CRA Compliance Team
What You'll Learn
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.
- Apply IEC 62304 lifecycle requirements based on medical device risk classification.
- Use item templates to simplify and standardize your medical software compliance processes.
- Establish end-to-end traceability across development to accelerate regulatory audits and approvals.
Explore More
Explore Related Resources
- Case Study
ISO 62304 Compliance Software & ALM Webinar
A technical demonstration showing how to automate proof of evidence, enforce end-to-end traceability, and accelerate IEC 62304 compliance audits.
- Article
Implementing Functional Safety Requirements for Medical Devices
A practical guide detailing how to implement safety requirements, execute risk analysis (ISO 14971), and maintain full lifecycle traceability in safety-critical systems.
- Guide
Software as a Medical Device (SaMD) Regulatory Guide
An in-depth guide covering key lifecycle processes, verification, and regulatory expectations for standalone medical device software.
Accelerate Your IEC 62304 Compliance Today
Enforce full end-to-end traceability and streamline medical device software verification with Visure’s AI-driven ALM platform — start a free trial or watch a live demo of it in action.
FAQ
IEC 62304 Medical Device Software Compliance FAQs
Can’t find an answer? Contact our team →