UK Responsible person
                     UK Responsible Person: Ensuring Compliance in the UK
The UK Responsible Person (UKRP) is essential for non-UK manufacturers selling medical devices
in the United Kingdom. This representative acts as the primary contact with the UK’s Medicines
and Healthcare Products Regulatory Agency (MHRA), managing documentation, declarations, and
compliance checks. I3C Global offers expert UK Responsible Person services, ensuring seamless
regulatory compliance and facilitating safe market entry into the UK.
FDA QMSR: Quality Management for the U.S. Market
For medical devices entering the U.S. market, compliance with FDA Quality Management System
Regulation (QMSR) is critical. This regulation outlines quality standards that manufacturers must
meet to ensure product safety and performance. I3C Global provides consulting services to help
companies  implement  QMSR-compliant  quality  systems,  helping  clients  align  with  FDA
expectations.  This  proactive  approach  to  quality  management  reduces  the  risk  of  compliance
issues, ensuring a smoother path to market.
FDA Registration: Essential for U.S. Market Access
FDA Registration is a fundamental requirement for any company intending to sell medical devices
in the U.S. All devices must be registered with the FDA, and most require additional regulatory
approvals depending on device classification. I3C Global guides manufacturers through the FDA
registration process, ensuring that all requirements are met efficiently to facilitate market entry.
By providing expert support, I3C Global helps manufacturers avoid common pitfalls and accelerate
their path to regulatory approval.
FDA Certificate: Demonstrating Compliance with U.S. Standards
After  registering  with  the  FDA,  medical  device  manufacturers  can  obtain  an  FDA  Certificate,
demonstrating compliance with the FDA’s regulatory requirements. This certificate acts as proof of
quality and regulatory adherence, reinforcing trust and credibility among customers and partners.
I3C Global assists clients in acquiring their FDA certificate, ensuring that they meet all necessary
standards for a successful and compliant launch in the U.S. market.
Clinical Evaluation Plan: Ensuring Device Safety and Effectiveness
A clinical evaluation plan is a comprehensive strategy for assessing the clinical performance and
safety of a medical device. This plan is a regulatory requirement in various markets, including the
EU and UK, and is essential for demonstrating a device's safety and effectiveness. I3C Global helps
manufacturers  develop  robust  clinical  evaluation  plans  that  align  with  global  standards,
supporting a successful regulatory submission and ongoing compliance.
Post-Market Surveillance: Maintaining Compliance and Safety
Post-market surveillance (PMS) is an essential part of regulatory compliance for medical devices,
requiring manufacturers to monitor their products’ performance and safety after market entry.
PMS helps identify potential risks and enables corrective actions if needed. I3C Global provides
comprehensive PMS support,  assisting manufacturers  in creating effective surveillance systems
that meet regulatory obligations, enhance patient safety, and reduce compliance risks over time.