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IEC 62304, as an internationally harmonized standard for medical device software lifecycle processes, is recognized by the FDA and other regulatory agencies across the world.

IEC 62304 provides guidance to the manufacturer on planning, development, and post market surveillance activities for medical device software to ensure companies are in compliance with both U.S. and other international regulatory requirements.

Consequently, IEC 62304 is a critical safety certification that ensures products work as intended and is safe for general use. However, keep in mind that without proper verification preparation, you can be blindsided by unforeseen requirements.

Experts in this area recommend that medical software companies follow a proven and systematized process to streamline the entire verification process. Beyond that, they also need to avoid the major mistakes that manufacturers make during the software development process.

For example, it’s essential to implement solid design control processes. Change control is essential to keep a full record of your documents and products. Theoretically, change control is feasible with a paper-based quality management system. But for more complex process changes, an electronic system can simplify the entire design and change control process.

There are always documents associated with any system—whether it’s an equipment file containing the manual and validation or a simple SOP change. An electronic quality management system (eQMS) makes it all visible to the required parties in real time. 

It’s also key to align documentation with IEC 62304 semantics. To ensure compliance, documents need to move in a predictable and traceable way through your company from one department to the next. Every move must be well-documented.

To avoid making a similar mistake, analysts recommend referring to guiding documentation. This guidance document outlines the recommended documentation you should include in premarket submissions.

Want to learn more? Tonex offers IEC 62304 Training, a 2-day course that provides requirements of IEC 62304 standard applied medical device software and Software Development Life Cycle (SDLC) Processes. IEC 62304 requirements and FDA expectations are discussed in a workshop style. 

For more information, questions, comments, contact us.

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