When was IEC 62304 created ?

IEC 62304 is an international standard published by the International Electrotechnical Commission (IEC) in 201The standard was created to address the growing importance of software in the medical device industry. It provides a framework for the entire software lifecycle, from design and development to deployment and maintenance.

The development of IEC 62304 was prompted by the increasing demand for medical devices that are equipped with software. As these devices become more complex and incorporate multiple software components, it is essential to have a standardized approach to software development and validation. IEC 62304 aims to provide just such a standard by establishing a comprehensive guide for the entire software lifecycle of medical devices.

IEC 62304 is a key international standard that outlines the software requirements for medical devices. It provides a structured approach to software development, including requirements for the entire software lifecycle, from design and development to deployment and maintenance. The standard is widely recognized and used by manufacturers, clinicians, and regulatory authorities as a guide to the development and validation of medical devices with software components.