While the earlier Medical Device Regulations referred specifically to ISO 9001, the new regulations no longer stipulate a compulsory ISO standard. That said, ISO 13485:2016 is generally recognized as the industry standard for Medical Devices in the EU, and, while a manufacturer’s certification body can provide more detailed advice, ISO 13485 is likely to be a reliably compatible system for the new EU MDR and IVDR.
It is also worth mentioning that the ISO 13485 standard explicitly requires the effective selection and control of tasks performed by third parties. By ensuring that their supply chain is ISO 13845 certified, manufacturers can reduce their exposure to risk, as laid out in the new regulations. Argos Multilingual is one of a small number of LSPs who are already certified to the ISO 13845:2016 standard.
Working Closely With LSP
Working closely with a translation and localization provider who specializes in medical language services and is ISO registered is an important step in conquering the ever-changing international regulatory process. The choice of translation provider is vital to ensure that translations are accurate, consistent, and technically correct.
Medical language service providers should be able to provide documented processes that involve native-speaking linguists that have expertise in both translation and the medical devices industry. To deliver consistency, quality, and reduced costs, the LSP should also integrate terminology management and computer-assisted translation solutions with its team of human linguists.
It is important to recognize the difference between providers who are actually certified and those who only present themselves as ISO “compliant.” The difference is as significant as a medical device manufacturer “promising” the European Union compliance to the respective directives and not physically displaying a CE mark. In the eyes of government regulatory agencies, an ISO certified language service provider is equivalent to having an in-house translation and localization department with approved processes that may be audited at any time.