What We Do
Medical devices and Brexit!! The UK’s withdrawal from the EU on January 31, 2020 will affect trade in medical devices and in vitro research. More than 20,000 UK manufacturers and almost double that number of manufacturers are seeking UKCA accreditation in the coming years. Many of these two regions are working hard on MDR requirements, updating technical dossiers and re-evaluating clinical trials of devices. We are the leading medical device regulator in the UK and provide comprehensive support to companies seeking to achieve timely approval, registration and small domestic services.
The new regulations MDR 2017/745 for medical devices and IVDR 2017/746 for invitro research devices have raised major compliance issues for certified and new companies. I3CGlobal provides legal support for companies looking to achieve rapid compliance with less inhouse manpower.
Complete medical device regulatory consulting and assist for registration, 510k guidance and US agent for all kind of gadgets. The service offer comes with the assurance of achievement. also the carrier offer comes with constant fees tag.