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Link: https://www.freyrsolutions.com/blog/iec-62304-compliance-the-complete-guide-to-medical-device-software-development-without-the-pitfalls

IEC 62304 Compliance

IEC 62304 Compliance refers to adherence to the international standard that defines the software life cycle processes for medical device software. This standard is essential for manufacturers developing Software as a Medical Device (SaMD) or software embedded in medical devices, ensuring safety, quality, and regulatory acceptance across global markets.IEC 62304 provides a structured framework for planning, developing, testing, maintaining, and retiring medical device software in a controlled and traceable manner.
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