FDA Requirements for English Translations: Key Guidelines for Compliance
In today’s globalized healthcare market, manufacturers, researchers, and healthcare providers often work with documents originally drafted in languages other than English. When submitting regulatory documentation to the U.S. Food and Drug Administration (FDA), it is imperative that these documents be translated accurately into English. The
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
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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