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 dynamic and customer-centric organization committed to honesty, integrity, and fairness.

**Expertise & scope**
* Expert services for MHRA registration and UK Responsible Person (UKRP) appointments.
* Support for CE marking under MDR and IVDR.
* Ensuring compliance with EU, USA, and UK Regulations.
* Specialization in Food, Cosmetic, Drugs, and Medical Device Regulatory Consulting Services.

**Reputation / proof points**
* Certified with ISO 27001 for data security.
* Operates with a 24/7 uptime guarantee, maintaining and securely delivering documents via the cloud.

Additional information

i3CGlobal (UKRP) emphasizes the complexity of regulatory documentation and registrations, advising that these tasks are best entrusted to regulatory experts. They highlight their readiness to initiate projects swiftly with a dedicated team of full-time regulatory experts, prioritizing on-time delivery. Their clear and consistent pricing is noted as an attraction for global customers who value transparency and quality assurance. Data security is a key focus, with ISO 27001 certification ensuring the confidentiality and integrity of client information.

Key Highlights

  • Specializes in UK Responsible Person (UKRP) appointments and MHRA registration for medical devices. Source
    “We are designated as UK Responsible Person.”
  • Provides expert services for CE marking under both MDR and IVDR regulations. Source
    “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.”
  • Certified with ISO 27001 for data security, ensuring confidentiality and integrity of client information. Source
    “Certified with ISO 27001 for data security, we go the extra mile to ensure the confidentiality and integrity of your information.”
  • Offers 24/7 uptime guarantee for secure document delivery via the cloud. Source
    “Operating around the clock with a 24/7 uptime guarantee, we diligently work, maintain, and securely deliver documents via the cloud”

Certifications & Trust Signals

  • Certified with ISO 27001 for data security. Source
    “Certified with ISO 27001 for data security”

Buyer Snapshot

Best for
  • Medical device manufacturers seeking UK Responsible Person services.
  • Companies needing assistance with MHRA registration.
  • Businesses requiring support for MDR and IVDR compliance.
How engagement typically works
  • Customer-centric approach.
  • Focus on honesty, integrity, and fairness.
  • Emphasis on on-time delivery and transparent pricing.
Typical deliverables
  • UK Responsible Person appointment.
  • MHRA registration support.
  • CE marking documentation (MDR/IVDR).
  • Regulatory documentation and registrations.
Good to know
  • Best when requiring expert handling of complex regulatory tasks.
  • Best when data security and confidentiality are paramount.
HQ: London, UK
Languages: English
Timezones: Europe/London
Claim status: Listed

Services & Capabilities

Best UK Responsible Person (UKRP) | Compare & Get Quotes

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 overseas manufacturer and the UKRP, including firm names and addresses for both parties. This document must confirm the UKRP operates with the manufacturer's agreement and that devices comply 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.
Request quotes
⚡ Instant booking available
Appoint a UK Responsible Person for UKCA Medical Devices
Compare i3CGlobal (UKRP) and other vetted providers — instant pricing, no RFQ needed.
Book now — instant pricing →
Cruxi - Regulatory Compliance Services