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New EU medical device regulations are approaching fast – what role will translation and localization play in making them viable? Manufacturers of medical devices for the EU market will soon have more requirements to comply with as part of the European Medical Device Regulation (MDR) for general medical devices and the In-Vitro Diagnostics Regulation (IVDR) […]

The October deadline is approaching, and the new government of the United Kingdom seems committed to a “no-deal” Brexit. It’s time to look at potential pitfalls that may not have gotten the attention they deserve. Every day seems to bring a new revelation about the unforeseen consequences of a “no-deal” or “hard” Brexit – the […]

With its 30% share, Europe is a big player in the medical devices market. European regulations controlling manufacturing, marketing and usage of the medical devices, also controls the language requirements for the medical devices that will be sold in the European Union. Since its first introduction in the 1990’s, one of the important consequences of […]

With the deadline for the implementation of the new Medical Device Regulation (2017/745) approaching, many life sciences companies, in particularly medical device manufacturers are in preparation mode. Executing a current state-analysis is the first step, but many companies are still unsure about what it is that’s changing and to what extent these changes will affect […]

In healthcare things simply cannot get lost in translation. While the world is getting smaller, the amount of regulations which control the field increases, as caused by the crucial importance of high-quality delivery in medical and pharmaceutical translations. What are the five main reasons why an increased number of key players in the industry entrust […]

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 […]

We are in the middle of the globalization age. It is impossible to stay inside your borders and hope to improve your business. To succeed, it is almost necessary that your company enter new markets. At this step, it is really easy to overlook the importance of localization. We are aware that localization is as […]