What Is IEC 62304?

Yes, IEC 62304 is recognized by the U.S. Food and Drug Administration (FDA) as a consensus standard for medical device software. Following IEC 62304 guidelines helps manufacturers demonstrate compliance with FDA regulations for the development and maintenance of medical device software during software testing.

IEC 62304 is an international standard for medical device software, while the FDA (U.S. Food and Drug Administration) regulates medical devices in the United States. Compliance with IEC 62304 demonstrates adherence to global standards, while FDA approval is necessary for marketing medical devices in the U.S.

IEC software standards, like IEC 61508 and IEC 62304, establish guidelines for the development of safety-critical software systems. They aim to ensure the reliability, safety, and maintainability of software in various industries.

IEC 62304 outlines requirements for the software life cycle in medical device development. Key requirements include defining processes, managing risks, conducting verification and validation, and maintaining traceability.

Compliance with IEC 62304 involves following the standard’s processes for the life cycle management of medical device software. It includes activities such as risk management, software development, and maintenance.