Why Leading Manufacturers Choose I3CGlobal Medical Device Consultants
Partner with I3CGlobal world-class medical device consultants in India, USA and UK for FDA 510k, EU MDR, IVDR and ISO 13485/GMP/QMSR compliance. Our proven expertise helps manufacturers launch safe, compliant products across global markets.
Client-Centric Approach
I3CGlobal is committed to providing its clients with personalized and responsive service. They take the time to understand each client’s unique needs and challenges and develop solutions that are tailored to their specific circumstances. This client-centric approach is reflected in the following:
- Dedicated Project Teams: I3CGlobal assigns dedicated project teams to each client, ensuring that they have access to the expertise and support they need.
- Regular Communication: I3CGlobal maintains regular communication with its clients, providing updates on project progress and addressing any questions or concerns.
- Flexible and Adaptable: I3CGlobal is flexible and adaptable, able to adjust its approach to meet the changing needs of its clients.
- Long-Term Partnerships: I3CGlobal strives to build long-term partnerships with its clients, becoming a trusted advisor and resource.
This commitment to client satisfaction has earned I3CGlobal a reputation for excellence in the medical device consulting industry.
Proven Track Record of Success
I3CGlobal has a proven track record of success in helping medical device manufacturers achieve their goals. They have assisted numerous companies in:
- Obtaining regulatory approvals: I3CGlobal has helped manufacturers obtain regulatory approvals for a wide range of medical devices in key markets around the world.
- Improving quality management systems: I3CGlobal has helped manufacturers improve their QMS, resulting in increased efficiency, reduced costs, and improved product quality.
- Successfully navigating audits: I3CGlobal has helped manufacturers successfully navigate audits by regulatory agencies and notified bodies.
- Gaining market access: I3CGlobal has helped manufacturers gain market access for their products, resulting in increased sales and revenue.
This track record of success is a testament to I3CGlobal’s expertise, experience, and commitment to client satisfaction.
Medical Device Consultants with Global Presence and Local Expertise
India & Asia
Cost-effective technical documentation and quality management system implementation with global standards.
European Union
MDR/IVDR transition support, CE Marking, and Clinical Evaluation Reports from our Germany and UK offices.
United Kingdom
Technical Documentation for UKCA and Certification Body Follow up until Certification is granted
United States
FDA 510(k) submissions, QMSR support, and 21 CFR 820 compliance guidance with deep knowledge of US regulatory requirements.
I3CGlobal Medical Device Consultants Core Competence
🇺🇸 US FDA Regulatory Support – United States
Entering the US medical device market requires a clear FDA regulatory strategy and full compliance. I3CGLOBAL provides complete end-to-end FDA regulatory support, including:
- 510(k) Submission Preparation – Complete premarket notification documentation and submission
- De Novo Classification Requests – Regulatory pathway support for novel devices
- FDA Liaison Services – Direct coordination and communication with the FDA
- QMSR Compliance (21 CFR Part 820) – Quality system guidance and audit readiness
- US Agent Services – Official FDA representation for foreign manufacturers
- Facility Registration & Device Listing – Initial and annual FDA registration support
- Initial Importer Services – Compliance support under 21 CFR 803, 806 & 807
With 25+ years of regulatory expertise, I3CGLOBAL ensures a smooth and compliant entry into the US market.
🇪🇺 MDR & IVDR CE Marking Support – Europe
Entering the European medical device and in vitro diagnostic market requires CE certification (or self-declaration, where applicable) and proper affixing of the CE mark.
I3CGLOBAL provides complete end-to-end EU regulatory support, including:
- Technical Documentation Preparation – Full MDR/IVDR documentation and Notified Body coordination until CE certification
- European Authorized Representative (EC REP) Services – For non-EU manufacturers
- EUDAMED & UDI Support – Registration and compliance management
- Clinical Evaluation Service for Medical Devices
- Performance evaluation service for IVD devices
- World-Class Facility Layout Guidance
- GMP – Implementation and Third Pary Audit. Service
With 25+ years of regulatory expertise, I3CGLOBAL has successfully supported 400+ CE certifications covering over 1,600 devices across multiple risk classes.
🇬🇧 UKCA Marking Support – Great Britain
Entering the Great Britain medical device and in vitro diagnostic market requires UKCA certification (or self-declaration, where applicable) in compliance with UK MDR requirements.
I3CGLOBAL provides complete end-to-end UKCA regulatory consulting services, including:
- Technical Documentation Preparation – Full documentation support and coordination with Approved Bodies until UKCA certification is granted
- UK Responsible Person (UKRP) Services – For non-UK manufacturers
- MHRA Registration Support – Device and manufacturer registration assistance
- QMS Implementation (ISO 13485) – Quality system setup and compliance guidance
With 25+ years of regulatory expertise, I3CGLOBAL has the necessary technical and regulatory expertice to support the new UKCA mark regulation for domestic and foreign manufactures