Safety first. When it comes to patient welfare, safety is always the goal. This is why the localization of medical software is a topic worth discussing. In the context of medical software, localization refers to adapting the strings of text in computer software to different languages, regional peculiarities, and technical requirements of a target locale. Medical software influences a patient’s health. A fault or bug in the code can put a patient at risk. But risks can also stem from a lack of proper translation of the languages used for medical device software. With more than 1.5 million medical devices available in homes, medical offices, and hospitals, there is ample need for the localization of medical software.
Where Medical Device Regulations Come Into Play
Medical software aids in decisions that affect patient care. It is vital that manufacturers build their software to meet medical device standards. Meeting those standards is not mandated, but will help ensure companies build software safely. Developing software with medical device standards will save you time and money if at a point your software is considered a medical device. Tackling these standards up front instead of at a later date will be most beneficial.
What is Medical Device Software?
Some software programs are already considered medical devices, which come with their own set of regulations. The International Medical Device Regulators Forum (IMDRF) defines software that is a medical device as, “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” Medical device regulators from across the globe came together as a part of IMDRF to determine the framework and principles that enable stakeholders such as regulators to protect patients and promote safe innovation.
Medical device software has to meet strict manufacturing standards that help ensure quality. These standards vary by country. In the United States, the FDA and HIPPA set these standards. In Europe and Canada, the standards are set by the ISO and IEC commissions.
What is Not Medical Device Software?
Not all software programs utilized in making medical devices are regulated by medical device standards. For example, software that controls a medical device isn’t considered to be an actual medical device. Other examples include software that relies on data from a medical device, but which does not have a medical purpose. Software used to enable medical workflow such as scheduling patient visits. And the software used to monitor the performance and functioning of a medical device.
Why the Localization of Medical Software Matters
Even if the software is not seen as a medical device, the localization of medical software is of vital importance. Not only on the safe side, but on the business side as well. In order to market a medical device and its accessories in a foreign market, companies must remain compliant with any international and local regulations. Instruction for use, packaging, labeling, and manuals must be presented in the national language of each country it is registered.
Typically, user interface translation is one of the key areas of translating medical device software, as any language confusion while using medical software can have perilous results. The FDA and the European Medical Device Directive are extending their purview to medical software. This is to ensure that medical software functions correctly. As well as to help users and health care providers know how to use the software in its intended way in each territory.