SO 13485 is a quality management system created specifically for medical devices. The term medical device is a specialized term that takes on its own meaning within this standard. A medical device is any instrument, apparatus, device, machine, equipment or reagent for in vitro use, as well as any computer program, material or other similar or related article intended by the manufacturer to be used by persons for a sanitary purpose.

In more natural language, software used to make clinical diagnoses, for example, can be considered a medical device.

The ISO 13485 standard is not obligatory, and is therefore a voluntary standard. It instructs on the need to introduce into the standard those regulatory aspects specific to each country. Although it is not mandatory, it is a very popular standard in the sector, to the extent that some translation companies have incorporated it into their list of certifications. In fact, many auditors of this standard are surprised when a translation company applies for this certification, but if you look at the big names in the translation industry, you will find that all these companies have been certified for years. The fact is that the standard is not only aimed at manufacturers of medical devices but also at their suppliers, which is what justifies translation companies being able to certify with this standard.

The adoption of the standard by the sector is such that the FDA itself has the intention of harmonizing and modernizing the current US regulation on medical devices, in such a way that the current requirements will be supplanted by the specifications of ISO 13485:2016. It is estimated that the new proposed rule will be issued in Fall 2019.

ISO 13485 is a quality management system that shares many points in common with ISO 9001, so a company that already has the ISO 9001 certification will find it easier to create the necessary documentation, as it will only have to include some specific parts developed in ISO 13485 applicable to medical devices. In the case of translation companies, adaptation will be made even easier by the fact that many of these specific parts are not applicable to them because of the nature of the service itself.

Translation requirements in ISO 13485

ISO 13485 does not specifically name translation as one of the procedures that has to be defined in the standard. The fact that translation activity is included de facto as a procedure is because it is a provision of services related to the life cycle of a medical device when these products are exported to other countries and the need arises to translate their labeling, instructions for use and marketing material. Therefore, the translation must comply with the requirements that the standard establishes for the activities carried out by a manufacturer of medical devices. Generally speaking, the standard will also establish a system for the selection and control of suppliers, which will also affect providers of translation services.

Regulation (EU) 2017/745 for medical devices, and its counterpart for in vitro diagnostic medical devices, Regulation (EU) 2017/746, establish the obligations of manufacturers that must be assumed by distributors and importers, stating that these “shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date.” In the case of a European manufacturer, distributor or importer, it will be imperative for a regulatory implementation of ISO 13485 that their document system includes a documented procedure in relation to translation.

ISO 17100 vs. ISO 13485

ISO 17100 is an exclusive standard for translation services in force since November 2015. It is an update of the European standard EN-15038 of 2006, which it cancels and replaces. This international standard specifies the requirements for all aspects of the translation process that have a direct impact on quality. It establishes, among other actions, minimum qualification requirements, availability and resource management. A fundamental aspect of the standard is that it establishes a defined translation process that requires a revision step. The reviewer, who must be different from the translator and have the skills specified in the standard, must compare the content of the target language with that of the source language in search of errors and to check the suitability for the intended purpose of the translation.

ISO 13485: A quality management system created specifically for medical devices.

ISO 17100: An exclusive standard for translation services, specifying the requirements for all aspects of the translation process that have a direct impact on quality.

reagent: A substance used for detecting or measuring because of its chemical or biological activity, such as a component in preparing a product, or in developing photographs.

Faced with this specificity of the ISO 17100 translation services standard, ISO 13485 only establishes a quality management system that generically affects translation and, in the case of its implementation in the EU, this system should specifically guarantee that the translation is “accurate” and “up-to-date.” How it is established that a translation is “accurate” is left to the discretion of the translation company itself, but endorsed by auditors and certification bodies. The MEDDEV guides themselves, a series of documents drawn up by the competent authorities and stakeholders involved with the aim of assisting companies to implement in a homogeneous manner the directives on medical devices in the European Union, are not much more specific than the quoted regulation itself in relation to translation. The MEDDEV 2.5/5 Rev. 3 guide for the translation procedure reads: “As part of the quality system or of the documents defining the manufacturing process, the manufacturer should have procedures for ensuring accurate translation of e.g. labelling, instructions for use and product claims in marketing material.

These are especially important for user instructions where the safety and claimed performance of the device may be compromised through inadequate translation.”

It is therefore the manufacturer, distributor or importer or, in our case, the translation company that is certified under the standard, that establishes a translation procedure to generate “accurate translations.”

Recommendations for an adequate translation procedure

As we have seen so far, the ISO 13485 standard does not establish any specific requirement on how translations should be managed, unlike ISO 17100, which does establish it and requires its compliance. ISO 17100 establishes a specific work process in which all translations must be reviewed. One way to ensure a translation procedure according to ISO 13485 criteria is to adopt the ISO 17100 translation process on translation services by establishing specific requirements on medical devices. Using the basis of the ISO 17100 standard is recommended because it is a standard created by professionals in the translation and localization sector, and it certainly describes a process through which we will be able to guarantee the quality of our translations. This will ensure that we have ample arguments to show the certification body auditor that our quality management system produces “accurate” translations. In fact, if we outsource the translations as a manufacturer, the requirement that the translations should be done by ISO 13485 or ISO 17100 certified companies would be sufficient to meet the requirements of the standard.

However, while ISO 13485 does not require a specific process to carry out our translations, but simply a documented process that meets the requirements of the standard, there is full freedom to establish the process we want, as long as we guarantee the accuracy of the translation. Even though translation companies strive to make clients understand the suitability of establishing a second revision step as a necessary quality control — an imperative for a translation to be carried out according to the criteria of the ISO 17100 standard — the budgetary requirements of many companies cause pressure to reduce costs. In this way, we find manufacturers, distributors and importers of medical devices that carry out translations without carrying out quality controls. We find translation companies offering translations that do not comply with ISO 13485 or ISO 17100, and sometimes without any control over the quality and accuracy of the translation. In the case of medical devices, this can pose a risk that can have high costs for the actors involved and we can say, without fear of exaggerating, risk people’s lives. Few people would think of buying a car that had not undergone quality controls such as whether the brakes were working properly.

The various legislations on medical devices, and certainly the American and the European legislations, offer a classification of medical devices according to the risk for the patient. We are all aware of the fine balance between price and quality: the medical translation and medical device sector is a very sensitive sector where quality must inevitably take precedence over price. Having said this, the different risk classifications for the patient according to the geographical area of interest can be used as a decision factor when establishing the translation process of our ISO 13485 standard and, in no case, renounce to an independent review process in those products classified as high risk. If you are a translation service provider with clients in the healthcare sector, you can access different databases to consult the risk classification and take them into account in your offers.

Conclusions

ISO 13485 is a quality management system used both by manufacturers, importers and distributors of medical devices and, to a lesser extent, translation companies specializing in this sector. Both this standard and the legislation do not specify a translation process to obtain “accurate” translations, so the process and its certification is the responsibility of the companies involved in the life cycle of a medical device, including translation companies, and of the certification bodies. In any case, it is advisable to take into account the risk classification for patients of the medical device we are going to translate and opt for the ISO 17100 translation process as a safe and proven solution to establish the ISO 13485 translation procedure and ensure compliance with it and its approval by the most demanding certification bodies.