MDR extension? What does that mean for me? UKCA pushed back. Where's the guidance? 

Having worked in the medical device quality and regulatory space for the majority of my professional career, I and the organisations I've represented have often faced challenges in navigating the landmine that is EU, UK, and US law. I have often sought answers on Google but end up opening 50 tabs, all saying the same thing but not helping me answer the question.

Here, you'll find information, templates, guidance documents, and the latest news from the medical and IVD worlds. You will find an environment where information is shared clearly and concisely, with one purpose: to ensure compliance so the end user can get the medical product he or she deserves.

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