IEC 62304 is an international standard medical device software that defines an agreed upon framework for processes that occur throughout the product lifecycle.

IEC 62304 applies to medical device development when software is an integral component to medical device production. It defines the software lifecycle when the software stands alone as a medical device (commonly referred to as software as a medical device, or SaMD), is a component of a medical device, or is used in the production of a medical device.

FREE DOWNLOAD: What influences medical device software classification? Click here to download a free PDF to learn the important factors of SaMD classification.

What is IEC 62304?

IEC 62304 is an internationally harmonized standard for medical device software lifecycle processes, recognized by FDA and other regulatory agencies across the world. IEC 62304 provides guidance to the manufacturer on planning, development, and postmarket surveillance activities for medical device software to ensure companies are in compliance with both U.S. and other international regulatory requirements.

An earlier release of IEC 62304 was less clear, but a 2006 amendment to the standard clarifies the requirements. IEC 62304:2006 provides guidance to manufacturers on how to identify hazards that could arise from software failure or defect, in order to properly classify the risk of a medical device. Based on the device risk classification, IEC 62304 provides guidance for risk control measures that must occur throughout the life cycle of that particular device.

What are the IEC 62304 Software Classifications?

IEC 62304 identifies three safety classes for medical device software:

  • Class A: No injury or damage to health is possible.
  • Class B: Injury is possible, but not serious.
  • Class C: Death or serious injury is possible.

This classification scale helps the manufacturer to identify the safety-related processes needed throughout the lifecycle of the medical device software. The applicable requirements are specific to the development and coding, release, and maintenance of medical device software. They are codified in the components of IEC 62304.

What are the Components of IEC 62304?

IEC 62304 for medical device software development delineates components into five clauses, numbered 5 through 9.

  • Clause 5: Outlines the software development process from planning to release.
  • Clause 6: Describes required maintenance of released software.
  • Clause 7: Specifies risk management required from assessing failures to identifying potential risks and implementing features to prevent them.
  • Clause 8: Lays out configuration management requirements regarding how to manage the development environment.
  • Clause 9: Explains problem resolution processes with regard to tracking and evaluation to address issues as they arise.

IEC 62304 Compliance is simplified with Greenlight Guru’s medical device QMS software

The best approach to medical device software development is risk-based, structured and methodical. Traceability throughout the lifecycle of medical device software is key to ensure compliance with IEC 62304.

Greenlight Guru's medical device QMS software is an easy to use, cloud-based software solution that promotes risk-based processes to be carried out throughout the entire medical device software lifecycle. 

With full traceability of quality procedures, companies can ensure requirements are being met for compliance, key players have up-to-date access to documents, and all information is securely stored to accelerate product development and improve the overall quality of a medical device.


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