i3CGlobal (UKRP)

i3CGlobal

i3CGlobal is a trusted regulatory consulting company specializing in medical device compliance for the UK and EU markets. They offer expert services for MHRA registration, UK Responsible Person (UKRP) appointments, and CE marking under MDR and IVDR.

i3CGlobal provides world-class regulatory consulting services for medical device manufacturers seeking to place their products on the UK and EU markets. As a trusted partner, they offer comprehensive support for navigating complex regulatory landscapes, including MHRA registration and acting as the UK Responsible Person (UKRP) for post-Brexit compliance. Their expertise covers essential services such as MDR and IVDR technical file preparation, clinical evaluation reports, risk management, and CE marking. i3CGlobal is committed to ensuring your devices meet all applicable laws and guidelines, offering a reliable and efficient pathway to market access. They also provide support for UKCA technical documentation and ISO 13485 implementation. With a focus on data security, certified by ISO 27001, and operating 24/7, i3CGlobal ensures the confidentiality and integrity of your information while delivering services promptly. They are dedicated to providing fair pricing and on-time delivery, making them a go-to choice for manufacturers worldwide.

About

**Who they are**
i3CGlobal (UKRP) is a regulatory consulting company specializing in medical device compliance for the UK and EU markets. They are a trusted partner for healthcare product manufacturers worldwide.

**Expertise & scope**
* Expert services for MHRA registration.
* UK Responsible Person (UKRP) appointments.
* CE marking under MDR and IVDR.
* Consulting for EU Medical Device Regulation, USFDA, USFDA Drug, US FDA Food, and FDA Cosmetic regulations.
* Specialization in IVDR CE Marking, IVDR Regulation, IVDR Technical File, IVDR Consultants, IVDR Classification, Software CE Marking, and IVDR PRRC.
* Expertise in MDR CE Marking, MDR Classification, Technical File, MDR Consultants, Clinical Evaluation, PMS Report, Risk Management, MDR Article 117, Software CE Marking, Biocompatibility Test, and MDR PRRC.

**Reputation / proof points**
* Certified with ISO 27001 for data security.
* Operates with a 24/7 uptime guarantee.

Additional information

i3CGlobal (UKRP) emphasizes the complexity of regulatory documentation and registrations, recommending entrustment to regulatory experts. They highlight their readiness to initiate projects swiftly with a dedicated team of full-time regulatory experts, prioritizing on-time delivery. The company offers clear and consistent pricing, attracting international clients who value transparency and quality assurance. Data security is a key focus, with ISO 27001 certification ensuring the confidentiality and integrity of client information, managed securely via the cloud.

Key Highlights

  • Specializes in UK Responsible Person (UKRP) appointments for medical devices. Source
    “We are designated as UK Responsible Person.”
  • Provides expert services for MHRA registration. Source
    “They offer expert services for MHRA registration”
  • Offers CE marking services under both MDR and IVDR. Source
    “and CE marking under MDR and IVDR.”
  • Certified with ISO 27001 for data security. Source
    “Certified with ISO 27001 for data security”

Certifications & Trust Signals

  • ISO 27001 certified for data security. Source
    “Certified with ISO 27001 for data security”
  • Operates with a 24/7 uptime guarantee for secure cloud documentation. Source
    “Operating around the clock with a 24/7 uptime guarantee”

Buyer Snapshot

Best for
  • Manufacturers seeking UK Responsible Person services.
  • Companies needing MHRA registration support.
  • Businesses requiring CE marking assistance under MDR/IVDR.
How engagement typically works
  • Project-based consulting.
  • Partnership for regulatory compliance.
Typical deliverables
  • UKRP appointment and agreement.
  • MHRA registration documentation.
  • Technical files and regulatory strategy.
  • CE marking documentation.
Good to know
  • Best when requiring specialized UK regulatory expertise for medical devices.
HQ: London, UK
Languages: English
Timezones: Europe/London
Claim status: Listed

Services & Capabilities

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Jurisdictions: UK
Countries: GB
Industries: Medical devices, IVD, Healthcare
Portfolio: 1-5, 6-25
Onboarding time: 3–21 days
Pricing model: Per project
Starting from: GBP 1,200
Included services: UK Responsible Person (UKRP) designation, MHRA liaison and communications forwarding, Support for registration process readiness, Vigilance escalation workflows and FSCA coordination, Labeling check for UKRP identification
Supports GB: Yes
Supports NI: Yes
Device Classes Supported: Class I, Class IIa, Class IIb, Class III, IVD
MHRA Support: Yes
Can Be Named On Label: Yes
MHRA Portal Support: Yes
Vigilance Support: Yes

Additional uk_rp Details

Supports MDR
Yes
Supports IVDR
Yes
Supports GB
Yes
Onboarding Steps
Requires a mutually signed agreement (letter of designation) between the manufacturer and the UKRP, including firm names and addresses for both parties. This document must confirm the UKRP's operating agreement with the manufacturer and device compliance with applicable laws.
UK Entity Country
England
Vigilance Support
Yes
Post Market Support
Yes
Device Classes Supported
Not explicitly stated, but support for MDR/IVDR implies all classes.
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