Understanding the Importance of IEC 62304

May 9, 2016 - Dennis Miller, Principal Software Engineer



As software becomes an increasingly important component of medical devices, compliance with standards such as the International Electromechanical Commission (IEC) 62304 is essential.

What is IEC 62304?

IEC 62304 is the international standard that defines software development lifecycle requirements for medical device software.  This standard provides a common framework for companies to create software and is scalable depending on the level of injury the software can cause.  Because this standard is developed by the IEC, it is harmonized by the European Union (EU) and the United States (US), and can be used as a benchmark to comply with regulatory requirements from both of these markets. Although the FDA does not formally require companies to meet this standard, it is expected that a company is in compliance with the standard.

Why do we need a separate standard for software?

IEC 62304 covers all aspects of software development including, but not limited to, evaluating risks, developing requirements, design, implementation, verification, and maintenance.  Although there are already standards for many of these activities, it is important to have a separate standard specifically for software because it is dramatically different than electronics and mechanical development and can involve failures throughout the software development process. The standard was developed from the perspective that product testing alone is insufficient to ensure patient safety when software is involved. With software, seemingly trivial changes can have significant unintended consequences.

What is Minnetronix’ Philosophy for IEC 62304?

At Minnetronix, compliance to software standards such as IEC 62304 is a critical aspect of development to ensure patient safety and maintain regulatory compliance.  We create customized software development plans that document the mapping of IEC 62304 to Minnetronix’ Standard Operating Procedures (SOP) and support completing an IEC 62304 compliance report at the end of each project. Minnetronix believes that this defined software development process and complying to IEC 62304 forces proper planning, allows for solid estimates for software development, and produces more reliable software.