Pure Global (UKRP)
Pure Global
Pure Global offers AI-powered medical device regulatory consulting and market access services in over 30 markets. They provide streamlined registration, local representation, and post-market support with transparent, flat-fee pricing starting at $2,000 USD per year.
Pure Global specializes in accelerating market entry for MedTech companies through AI-driven regulatory solutions and global representation. With over 15 offices across five continents, they offer comprehensive services including dossier compilation, in-country representation, translation, modifications, distributor authorization, and post-market support. Their services are designed to navigate complex regulatory landscapes, ensuring compliance and efficient product registration in over 30 markets. Pure Global leverages AI and data tools to provide regulatory intelligence, monitor changes, and streamline compliance journeys. They offer a flat annual fee structure, starting at $2,000 USD per year for the first device, which covers a range of essential services. Key offerings include regulatory strategy, market research, classification and grouping, submission and registration, and post-market surveillance. Pure Global aims to minimize risks, reduce costs, and expedite the process of bringing medical devices to target markets worldwide.
About
**Who they are**
Pure Global (UKRP) is a global growth partner for MedTech companies, delivering AI-powered market access and regulatory consulting solutions. They combine real-world experience with AI and data to support medical device registrations and post-market compliance across more than 30 markets.
**Expertise & scope**
* AI-powered dossier compilation and local representation for medical device registration.
* Streamlined registration, local representation, and post-market support.
* Services include dossier submission, in-country representation, translation, modifications, distributor authorization, and post-market surveillance correspondence.
* Coverage extends to over 30 markets globally, including the United Kingdom.
* Offers AI-driven regulatory solutions and a global database for regulatory research.
**Reputation / proof points**
* Operates with a focus on honesty, quality, collaboration, and prioritizing customer needs.
* Emphasizes ethical standards, transparency, and accountability in its relationships.
Pure Global (UKRP) is a global growth partner for MedTech companies, delivering AI-powered market access and regulatory consulting solutions. They combine real-world experience with AI and data to support medical device registrations and post-market compliance across more than 30 markets.
**Expertise & scope**
* AI-powered dossier compilation and local representation for medical device registration.
* Streamlined registration, local representation, and post-market support.
* Services include dossier submission, in-country representation, translation, modifications, distributor authorization, and post-market surveillance correspondence.
* Coverage extends to over 30 markets globally, including the United Kingdom.
* Offers AI-driven regulatory solutions and a global database for regulatory research.
**Reputation / proof points**
* Operates with a focus on honesty, quality, collaboration, and prioritizing customer needs.
* Emphasizes ethical standards, transparency, and accountability in its relationships.
Additional information
Pure Global offers a transparent, flat-fee pricing model for their medical device regulatory consulting and market access services. Pricing starts at $2,000 USD per year for the first device, excluding government fees. This fee typically includes dossier compilation, in-country representation, translation services, modifications, distributor authorization, and post-market support. Buyers can utilize their Fee Calculator for instant estimates. The company emphasizes accelerating market entry through AI-powered solutions and local regulatory representation.
Key Highlights
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Offers AI-powered medical device regulatory consulting and market access services.
Source
“We are a leading trusted global growth partner to MedTech companies delivering smart and efficient market access solutions powered by transformative data & technology, high quality domain expertise.”
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Provides streamlined registration, local representation, and post-market support.
Source
“Accelerate market entry with AI-powered dossier compilation and local representation, all for a flat annual fee.”
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Transparent, flat-fee pricing starts at $2,000 USD per year for the first device (excluding government fees).
Source
“Starting at $2,000 USD per year for the first device (excluding government fees).”
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Covers services in over 30 markets globally.
Source
“We combine real-world experience with AI and data to build smart, efficient medical device regulatory consulting solutions for more than 30 markets.”
Certifications & Trust Signals
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Emphasizes ethical standards, transparency, and accountability.
Source
“Trust is the cornerstone of our relationships with customers, employees, and partners. We uphold the highest ethical standards, fostering an environment of transparency and accountability.”
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Operates with a mission to provide next-generation solutions for MedTech companies.
Source
“Our mission: we provide next generation solutions for MedTech companies to expand their global reach.”
Buyer Snapshot
Best for
- MedTech companies seeking global market access.
- Companies needing streamlined medical device registration processes.
- Businesses requiring AI-powered regulatory intelligence and support.
How engagement typically works
- Project-based for specific registrations.
- Ongoing support for post-market compliance.
- Partnership for comprehensive market access strategies.
Typical deliverables
- Compiled regulatory dossiers.
- In-country representation agreements.
- Translated submission documents.
- Post-market surveillance reports.
- Market access strategy consultation.
Good to know
- Best when requiring support in over 30 global markets.
- Suitable for companies valuing transparent, flat-fee pricing.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: Starting at $2,000 USD per year per device
Notes:
Based on publicly listed information; final fees depend on scope and exclude government fees.
“Starting at $2,000 USD per year for the first device (excluding government fees).”
HQ:
Boston, UK
Languages:
English
Timezones:
Europe/London
Status:
listed
Services & Capabilities
Best UK Responsible Person (UKRP) | Compare & Get Quotes
Jurisdictions:
UK
Countries:
GB
Industries:
Medical devices, IVD, Healthcare
Portfolio:
26-100, 100+
Onboarding time:
3–21 days
Pricing model:
Custom pricing
Starting from:
USD 7,000
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
MHRA Support:
Yes
Can Be Named On Label:
No
MHRA Portal Support:
No
Vigilance Support:
Yes
Additional uk_rp Details
Supports MDR
Yes
Supports IVDR
Yes
Supports GB
Yes
Vigilance Support
Yes
Post Market Support
Yes
UK Entity Country
England
Onboarding Steps
The company offers a Fee Calculator for instant estimates and provides guidance through the regulatory process.
