The importance of ISO 17100 when choosing a translation partner
Choosing a translation partner can be a challenging undertaking. You want a partner with an established quality assurance process, expertise in the languages you need, strong data security protocols, a responsive project management team, and last but not least a company that can meet your
New deadline for the certification of medical devices under the Medical Devices Regulation (MDR)
On 7 March 2023, the Council adopted a regulation that extends the deadline for the certification of medical devices under the Medical Devices Regulation (MDR). The measure aims to allow the MedTech industry to continue to bring essential equipment to the market and ensure that
Globalizing Smiles: Dentistry and Localization
A healthy picture-perfect smile has become a top priority and a beauty standard across the globe, partly motivated by celebrities and the vanity culture developed with social media. However, worldwide we can witness an increase in the prevalence of dental disorders due to smoking, aging,
Certified Translation of Instructions for Use for Medical Devices
The primary objective of the translation is to provide users with clear and understandable guidelines for properly using medical devices. The most important aspect to keep in mind involves legal issues. Countries in the European Union dictate that the proper translation of instructions of use
New European Union Medical Device Regulation
What is MDR? The MDR is the new regulation for medical devices and sanitary products. Its main objective is to establish new requirements for the production and supply of medical devices in European territories while meeting high quality and safety standards. It appeared in response
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Linguistic validation in clinical trials
In multicentre clinical trials, no result can be considered reliable if patients do not fully understand what they are being asked. This is the challenge addressed by linguistic validation: a methodological process that ensures a clinical instrument —such as a questionnaire, informed consent form or patient-reported outcome measure— conveys the same meaning across all languages and cultures in which it is used. Unlike conventional
