IEC 62304 – Medical Device Software Life Cycle Process Standard – Overview and Summary of Requirements for Software Development

IEC/EN 62304 has been adopted by the FDA and EU agencies as the standard by which they audit software used for medical devices. IEC 62304 outlines requirements for the following steps in the software life cycle process:

 

 

Complying with IEC 62304 ensures fulfilling requirements of the FDA Quality System Regulations, 21 CFR Part 820. Below are some of the most important points regarding software development detailed in the IEC 62304 standard.

 

SOUP of Software of Unknown Provenance is a software   that is already developed and generally available and that has not been developed for the purpose of being incorporated into the medical device. This is also known as off-the-shelf   software or   software   previously developed   for   which   adequate   records   of   the development processes are not available.

 

The manufacturer should assign a software safety class to each software system. These classes, according to IEC 62304 are:

 

 

IEC 62304 does not:

 

 

The medical device manufacturer should establish a software development plan for conducting software development activities. The software development life cycle model should be fully detailed and referenced in the plans.

 

The plan should include:

 

 

	Buy the standard, checklists and templates for complying with IEC 62304: Templates For Software Configuration Management Documents Version 5.0 Medical device software - Software life cycle processes Checklists Kit for Medical Device Firms Evidence Product Checklist For Standard IEC 62304:2006 Medical device software – Software life cycle processes   Or attend a ComplianceOnline webinar to learn more about IEC 62304: Aligning Medical Device Software Development with EU Requirements for a CE Mark (IEC 62304) 3-hr Virtual Seminar: Outsourcing Medical Device Software Development with Compliance to IEC 62304 Understanding the new International and FDA accepted Software Development Standard IEC 62304 Understanding the FDA guideline on ’Off-The-Shelf Software Use in Medical Devices’ and the pitfalls that are associated with using OTS software’

 

 

 

The plan should be updated regularly.

 

For the Class C category, the manufacturer should include standards, methods and tools for developing software in the plan.

 

The software development plan should also include information on verification:

 

 

The software development plan should include a plan to conduct risk management processes for all categories – A, B and C.

 

The software development plan should include details for all software related documentation. The plan should include the following for all documents:

 

The software development plan should include information about software configuration management. This should include or reference: