Since 1947, the International Organization for Standardization (ISO) has created thousands of quality control parameters for a variety of industries to ensure that global companies produce the safest consumer goods, including food, medicine, and vehicles.
While ISO standards are voluntary rather than mandatory, companies that meet or exceed these standards can be perceived as more reliable in the global marketplace and can also work together more effectively to promote policy and regulatory cooperation in their industries at a global scale.
Consumer safety is a priority in all ISO sectors, but perhaps none more so than the medical device industry. With medical devices, the smallest miscalibration or even a hint of ambiguity in user manuals can lead to ineffectual healthcare or even more dire consequences.
ISO 13485, most recently updated in 2016, provides standards for all organizations involved in the medical devices industry to prevent misuse. Adhering to these stringent quality control standards minimizes risks of injury and helps medical practitioners administer treatment correctly.
Because medical devices are often standardized and used around the world, medical device companies rely on language solutions partners (LSPs) to aid in the translation and localization of their products for different languages and countries.
Here’s an overview of why ISO 13485 is important to the language services industry, and how language solutions are essential to high-stakes industries like medical devices and healthcare.
What is ISO 13485?
The International Organization for Standardization defines a medical device as “a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.”
Examples of medical devices include wheelchairs, pacemakers, syringes, insulin pumps, defibrillators, and surgical instruments. They can be used by a patient or a healthcare provider as part of an annual exam, ongoing source of treatment, or short-term medical care.
Universally, medical devices go through extensive production, quality control, and regulatory processes before they are approved to go to market. According to the International Organization for Standardization, ISO 13485 “specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.”
This quality management standard pertains to any organization -- regardless of size -- involved in the product creation cycle of medical devices, such as design and development, production, storage and distribution, installation, marketing, or technical support. One such organization can be an LSP.
How do LSPs use ISO 13485?
As part of its quality management process, ISO 13485 outlines standards for LSPs that provide translation services for the medical industry, and specifically medical devices being marketed in foreign countries. The audience for this translated content can range from healthcare practitioners to patients, to regulators in the target country. In the medical devices industry, there are a variety of materials that require translation.
Words on the products themselves must be translated into the target language, and the marketing materials and literature about the devices require translation or tweaks for a new audience (for example, changing from the metric system to the standard system). LSPs also translate Instructions for Use (IFUs), user interfaces and software, and packaging and labels for medical devices to make sure the products are easy to identify and to use.
In addition to ISO 13485, many regions have their own regulations for medical device translation, such as the European Union’s Medical Device Regulation (MDR), that overlap with ISO standards. In-country regulators often require documentation for clinical trials, quality management system certificates, and other compliance documents, which must be translated in the target language, too.
To handle medical translations, LSPs should utilize subject matter experts in the healthcare industry who are familiar with medical terminology and can perform translations to the highest standard.
For more information on ISO, visit United Language Group’s quality page.