Medical translations are a particularly sensitive issue, where incorrect translations can quickly have serious consequences for the safety of users and/or patients. By meeting various strict criteria, ISO-certified translation agencies guarantee consistent, high-quality translations. In addition to the ISO 17100 standard for the translation industry as a whole, ISO 13485 has been specifically produced for medical devices and offers clients a range of benefits.
Anyone who works in the medical sector knows all about ISO 13485 and what it requires from quality management systems for medical devices – so in fact it doesn’t directly apply to the translation industry. However, as translations have a huge part to play in getting medical devices onto the market and in ensuring safety, they have to meet the same requirements as the manufacturers of the devices themselves. There are six key benefits to working with a translation agency with ISO 13485 certification.
Benefit 1: You know they’re specialists
Getting ISO certification takes a great deal of time and money, as the whole team has to be on board and meet the requirements in every aspect of their work. The figures show that this certification is no mere formality: only 9% of the world’s top language service providers are ISO 13485 certified.
So if your translation agency does have ISO 13485 certification, it’s a reliable indication that they specialize in medical translations – no one would go to those lengths if medical translations are just an occasional sideline for them. It shows the agency is a suitable place to go if you need to translate critical regulatory texts and that they have optimized their quality management system accordingly.
Benefit 2: No supplier audit required
Manufacturers of medical devices are required to conduct supplier audits for the more critical products and services they provide – but that’s only if the suppliers don’t have their own QM system. If the translation agency has its own ISO 13485 certification, there’s no need for medical device manufacturers to conduct this audit.
Benefit 3: Compliance with the MDR
In addition to ISO 13485, there are various directives and standards which medical device manufacturers must meet when placing their products on the market. One of them is the MDR (Medical Device Regulation), which came into force in 2021. If your translation agency has ISO 13485 certification, you don’t have to worry about MDR compliance as the ISO criteria are considerably more stringent.
Benefit 4: Machine translation can be used on request
You might think machine translation and medical technology don’t belong in the same sentence – but they can. Although DeepL and other machine translation engines normally exclude medical translations from their services, translation agencies with ISO 13485 certification can request special exceptions and obtain approval for use of these services, as their certification is proof that they have appropriate quality and risk management systems in place.
Benefit 5: Audited quality management gives you peace of mind and saves you money
Documented processes and a detailed quality management system, audited by an external body, ensure that a translation agency has efficient workflows and will produce high-quality texts. This will save you money – after all, it’s always the client who ends up paying for laborious and inefficient ways of working.
Benefit 6: Fully qualified translators
Translations of operating instructions and other documentation need to be perfect to ensure optimum safety for patients and users of medical devices. These can only be produced by professional translators specializing in medical technology and specific fields within it. ISO 17100 provides clear and stringent regulations governing the criteria translators and reviewers have to meet, so you can rest assured that you’ll get high-quality translations that meet your needs.
Main image: © MEINRAD
