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Our in-depth knowledge of European medical device regulations ensures that we can assist you in determining an efficient regulatory strategy for your device. Complying with the new Regulation (EU) 2017/745 (MDR) requirements may seem like a daunting task, particularly with a looming deadline, but Nerac can help you create the right documentation.
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Your trusted source for breaking news and expert analysis
Your trusted source for breaking news and expert analysis
Nerac works with manufacturers who have submitted technical files with reports we’ve authored for conformity assessments by the following European commission Notified bodies designated under the EU MDR (2017/745):
Your trusted source for breaking news and expert analysis
Medical Device / Regulatory Articles
Clinical literature reviews are critical components to achieving MDR compliance. Review of scientific literature may be needed for many EU MDR deliverables.
This article defines similar devices and best practices for similar device data included in state of the art evaluations and CERs under EU regulations.
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