MHRA Regulatory Compliance
Medical Device and Brexit!! The UK’s withdrawal from the EU on 31 January 2020 will have an impact on the trade in medical and in vitro diagnostics devices. More than 20000 manufactures from UK and almost double the number of manufactures looking for UKCA compliance in coming years. Large number from both areas are already struggling with the demands of the MDR, Technical File updation and reassessing clinical evaluation for devices. We are medical device regulatory consultant in UK and provide complete support for companies looking to find early compliance, registration with less inhouse manpower.
EU Regulatory Compliance
New MDR 2017/745 for Medical Devices and IVDR 2017/746 for Invitro Diagnostics Devices regulations have raised tremendous compliance issues for already certified and new companies. I3CGlobal provide regulatory support for companies looking to find early compliance with less inhouse manpower.
US FDA Regulatory Compliance
Complete medical device regulatory consulting and support for Registration, 510k preparation and US Agent for all type of devices. The service offer comes with the assurance of success. Also the service offer comes with fixed fees tag.
To be an independent, credible, and professional medical device regulatory consultant who treats all our customers fairly in our dealings with us. We try to build awareness amongst our customers of the regulatory role we will perform with your team and the work we do in advance to avoid future misunderstandings. We believe people who work and serve customers in our company should have sufficient knowledge and hands-on updated regulatory information. They are key in achieving early certification and clearance from regulatory bodies. This belief should be the cornerstone of an effective regulatory consulting service that benefits the customers and ultimately leads to customer referrals and the economic growth of our company.
~ Most projects are completed without consultants onsite; this helps reduce huge travel and allied cost.
~ Business / Documentation happens in the silicon valley of India, Bangalore. The largest technical pool of consultants and clinical writers works 24 x 7, 5 days a week.
~ Across Globe, regulatory outsourcing is a common practice, and find India a hot destination with economical pricing and tax benefits
~ Documentation move on the cloud. No matter where you are!!!