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, leveraging AI and data-driven solutions to facilitate market access and regulatory compliance. They combine domain expertise with technology to offer streamlined registration and post-market support across numerous international markets.
**Expertise & scope**
* AI-powered dossier compilation and local representation for medical device registration.
* Market access and regulatory consulting throughout the product lifecycle.
* Support for over 30 markets globally, with established local entities and partners.
* Services include dossier submission, in-country representation, translation, modifications, distributor authorization, and post-market support.
* Specialized knowledge of UK medical device regulations, including MHRA guidance.
**Reputation / proof points**
* Operates with a focus on honesty, quality, and customer needs.
* Has a presence in over 30 markets globally, with multiple offices on five continents.
Pure Global (UKRP) is a global growth partner for MedTech companies, leveraging AI and data-driven solutions to facilitate market access and regulatory compliance. They combine domain expertise with technology to offer streamlined registration and post-market support across numerous international markets.
**Expertise & scope**
* AI-powered dossier compilation and local representation for medical device registration.
* Market access and regulatory consulting throughout the product lifecycle.
* Support for over 30 markets globally, with established local entities and partners.
* Services include dossier submission, in-country representation, translation, modifications, distributor authorization, and post-market support.
* Specialized knowledge of UK medical device regulations, including MHRA guidance.
**Reputation / proof points**
* Operates with a focus on honesty, quality, and customer needs.
* Has a presence in over 30 markets globally, with multiple offices on five continents.
Additional information
Pure Global (UKRP) emphasizes a transparent, flat-fee pricing model for their services, starting at $2,000 USD per year for the first device, excluding government fees. This pricing typically includes essential elements like in-country regulatory representation, device registration compilation, dossier submission, translations, import authorizations, post-approval modifications, annual renewals, and post-market surveillance correspondence. Buyers should note that government and third-party fees are separate. Their AI-powered tools and extensive network aim to accelerate market entry and reduce the risk of application rejections.
Key Highlights
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Offers AI-powered dossier compilation and local representation for medical device registration.
Source
“Accelerate market entry with AI-powered dossier compilation and local representation, all for a flat annual fee.”
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Provides regulatory consulting and market access services in over 30 markets.
Source
“We combine real-world experience with AI and data to build smart, efficient medical device regulatory consulting solutions for more than 30 markets.”
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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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The MHRA is the UK's authority regulating medicines and medical devices.
Source
“The Medicines and Healthcare products Regulatory Agency (MHRA) is the United Kingdom’s (UK) authority that regulates the safety, quality, and efficacy of medicines, medical devices, and blood components for transfusion.”
Certifications & Trust Signals
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Pure Global has over 15 offices on five continents.
Source
“With over 15 offices on five continents, Pure Global's team of regulatory experts provide real-time, ongoing regulatory support for medical device registrations and post-market compliance.”
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Emphasizes honesty, quality, and effective collaboration in its operations.
Source
“We Work With Honesty; We Strive For Quality; We CollaborateEffectively”
Buyer Snapshot
Best for
- MedTech companies seeking global market entry.
- Businesses requiring streamlined medical device registration processes.
- Companies needing AI-driven regulatory intelligence and support.
How engagement typically works
- Project-based registration support.
- Ongoing regulatory consulting.
- Partnership for market access.
Typical deliverables
- Dossier compilation and submission.
- In-country representation.
- Regulatory strategy and pathway development.
- Post-market surveillance support.
Good to know
- Best when seeking predictable, flat-fee pricing for core services.
- Best when leveraging AI and data-driven regulatory solutions.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: Starting at $2,000 USD per year per device (excluding government fees)
Notes:
Based on publicly listed information; final fees depend on scope and include government/third-party fees.
“Starting at $2,000 USD per year for the first device (excludes government fees).”
HQ:
Boston, 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:
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 process involves AI-powered dossier compilation and local representation, dossier submission to local authorities, and post-market support.
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