Uncharted Waters: What Brexit Could Mean for Life Sciences in the UK
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. […] Read More
Will There Be More Translation Work After MDR2017/745
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 […] Read More
Understanding the Impact of the EU Medical Device Regulation (MDR) on IFUs
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, […] Read More
5 Reasons Why You Need Specialized Healthcare Translations
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 […] Read More
Certified Language Service Providers for MDR Regulation Changes
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 […] Read More