I3CGlobal For UK 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. I3CGlobal (Medical Device Regulatory Consultants) provide complete regulatory support for companies looking to find early compliance with less inhouse manpower.
I3CGlobal For 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.
I3CGlobal For US FDA Regulatory Compliance
Complete 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 Consultants that treats all our customers fairly in all of our dealings with us. We try to build awareness amongst our customers of the regulatory role we are going to perform with your team and the work we do in advance to avoid future misunderstanding. We believe people who work and serve customers in our company should have the sufficient knowledge and hands on updated regulatory information. They are key force in achieving early certification and clearance from regulatory bodies. This belief should be our cornerstone of an effective regulatory consulting service that benefits the customers and ultimately leads to customer referrals and economic growth of our company.
~ Most projects completed without the presence of consultants onsite, this helps reduce huge travel and allied cost.
~ Business / Documentation happens in the silicon Valley of India, the Bangalore. The largest technical pool of consultants and clinical writers works 24 x 7, 5 days a week.
~ Across Globe regulatory outsourcing a common practice and find India a hot destination with economic pricing and tax benefits
~ Documentation move on cloud. No matter where you are!!!