Medical Device Consultants and Regulatory Professionals are available to assist you.
We are one of the leading medical device consultants serving manufacturers with CE Marking, UKCA Mark, US FDA 510(k) (EN) ISO 13485:2016. 21 CFR 820 and more. Our firm delivers results faster! No matter what the device or how complex the device technology.
Documentation
We work for clients remotely, but customers can monitor the progress and quality of documentation wherever you are at any point of time.
Experienced medical device consultants with prior experience on particular device is selected for every projects. Each project will be monitored by team lead.
Every project with us will be taken care by at least 3 experts, which assures quality documentation and final review for onward submission to authorities on time.
We support (a) Manufactures (b) Initial Exporters (c) Initial Importers of Medical Devices intended to be sold in the USA.
Medical Device manufactures must implement and follow ISO 13485 if planning for CE or UKCA marking. We are ISO 13485 Consultants.
21 CFR 820 is important for medical device organizations to wish to demonstrate applicable regulatory requirements with FDA.
510k clearance is mandatory for most of the class II and class III devices to sell in USA. We are consultants for 510k.
We, CE Marking Consulting helps medical device manufacturers in commercializing their products in the EU market.
UKCA Mark Consulting helps in certification process starting from technical file preparation, testing and certification body submission
As a Medical Device Consultants we Provide End-to-end solutions for small, medium and large scale medical device manufacturers across the globe!
Why Choose I3CGLOBAL as your Medical Device Consultants?
I3CGLOBAL offers medical device regulatory consulting services in the EU, INDIA, the United States, and the United Kingdom. Our comprehensive regulatory support includes help with Technical Documentation, Testing, Clinical Evaluation, and Authorized Representative services for many countries.
I3CGLOBAL is an EN ISO 13485:2016 QMS certified, as well as an ISO 27001:2013 data security system certified company.
We provide complete medical device consulting including US Agent Service along with documentation and FDA Coordination.
The one-Stop service center for all your needs for CE Marking your Medical Device. No matter the risk class or State of the art.
We have in-house EU & UK Representation offices in Germany and UK for MDR and UKCA compliance for medical devices.