If you manufacture medical devices today, you’re likely quite familiar with two seasoned organizations and the voluntary international standards they develop and publish; the International Standards Organization (ISO) and the International Electrotechnical Commission (IEC).
In response to requests from experts around the world, including clinical professionals, academic researchers, and engineers representing device manufacturers, the ISO and IEC develop, negotiate, define, and publish technical standards that advocate design criteria and processes to ensure the safety, performance, and efficacy of devices and accessories that patients and health care professionals throughout the world use every day.
Many of the standards created by the ISO and IEC are recognized by organizations like the U.S. Food and Drug Administration (FDA), the National Medical Product Administration (NMPA formerly the CFDA), the Medical Device Single Audit Program (MDSAP), and the Australian Regulatory Guidelines for Medical Devices (ARGMD).
With medical technologies advancing at a record pace, so too is the software advancing that operates, records, and reports the data within these technologies. It’s difficult to imagine any medical device nowadays that doesn’t contain a user interface, program, or data logging system that leverages software above the functional firmware needed to operate the electronics of the system.
Software as a Medical Device Defined
The term medical device is most commonly associated with physical devices, but this isn’t always the case. The International Medical Device Regulators Forum (IMDRF) defines ‘Software as a Medical Device’ (SaMD) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."
IEC 62304 – “Medical Device Software – Software Life Cycle Processes” is an international standard by the IEC that defines the suggested requirements for software used in medical devices. Similar to the adjacent ISO standards 14971 and ISO 13485, IEC 62304 outlines the requirements for the development of medical software within medical devices by the use of a quality management system (QMS) and risk management process. Within this standard are guidelines to support the process for software development, maintenance, management, risk mitigation, configuration management, and problem resolution.
Managing Medical Software Risk
When managing medical device software risk, it is advisable to consider risk for all software that fits under the IMDRF definition, not only software that “lives” on medical device hardware. IEC 62304 is an internationally recognized and respected document, which has garnered the attention of medical device manufacturers across the globe.
For medical device manufacturers with legacy products, as well as those trying to get a product to market, one source of risk is Software of Unknown Provenance, or SOUP. SOUP is broadly defined as software already developed and generally available but has not been developed for the purpose of being incorporated into the medical device or software intended to be used for the purposes of a medical device. This includes ‘off the shelf’ software or software previously developed where adequate records of the engineering process are not available.
By using a software development process that is in accordance with modern standards, manufacturers will be able to establish system quality metrics, have greater consistency in the review process and ultimately confidence in the device performing as intended. Manufactures need to be sure they cast a sufficiently wide net when identifying which software should be subject to this type of risk management.
Planning for the Future
Benchmark Electronics is certified to many ISO standards and has a software development process that is fully compliant to IEC 62304. Using a phased gate approach and a proven verification and validation process, our team can help create robust software that is well-documented, manageable and accountable for both life enhancing and lifesaving technologies. Contact us today, to get your questions answered and to learn how Benchmark can help get your software certified.