Are You Ready for IEC 62304? Software Development Takes On New Role in Medical Manufacturing


Andy LaFrazia

The recent IEC 62304 standard has gotten a lot of hype lately, as manufacturers throughout the medical industry grapple with what is quickly becoming the industry go-to for medical device software development. The FDA has adhered to the standard since 2008, and it has become normative for CE marking in recent years as well.

This standard presents some challenges for software development, which has traditionally relied on a high level of flexibility throughout the development process. While IEC 62304 does require additional rigor, it’s also providing new opportunities for those companies who are ready to embrace it. Below, we’ve outlined some of the key aspects of the new standard.

What is IEC 62304?
IEC 62304 is a standard for medical devices, focusing primarily on the life cycle of software development for these devices as a separate process in itself. Previously software development has been considered as a part of the overall product life cycle, and therefore required only to be an aspect of overall product development.

The new standard reflects a growing sentiment of the importance of software in medical device development. Rather than simply being incorporated out of necessity into medical products, embedded software today is rapidly becoming the key factor in product differentiation for medical device developers.

What’s Included in IEC 62304
IEC 62304 is primarily focused on traceability. This means that each requirement for new products are mapped to distinct elements of software code. This means requirements must also be part of software development for manufacturers. Software will also require more robust testing at each stage of development. Documentation also takes on a larger role with IEC 62304, as this traceability and testing must be compiled to present to regulatory agencies.

At ControlTek, our medical device manufacturing, design engineering and software development processes are finely tuned to the medical industry. Our processes meet FDA requirements in order to maximize quality and reduce time to market while minimizing risk, and we take the time to understand product and software requirements upfront so we can proactively design a testing strategy for your new products.

Learn more about ControlTek’s Medical design engineering and medical device test development and documentation.

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