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 across more than 30 markets. They combine real-world experience with advanced technology to offer streamlined regulatory consulting.
**Expertise & scope**
* AI-powered dossier compilation and local representation for medical device registration.
* Market access and regulatory consulting throughout the product lifecycle.
* In-country representation and local distributor authorization.
* Post-market surveillance support and correspondence with authorities.
* Translation services for required submission documents.
* Support for modifications and annual renewals.
* Regulatory intelligence and news through their global database and AI tools.
**Reputation / proof points**
* Operates with over 15 offices on five continents.
* Focuses on transparency, accountability, and ethical standards in client relationships.
Pure Global (UKRP) is a global growth partner for MedTech companies, leveraging AI and data-driven solutions to facilitate market access and regulatory compliance across more than 30 markets. They combine real-world experience with advanced technology to offer streamlined regulatory consulting.
**Expertise & scope**
* AI-powered dossier compilation and local representation for medical device registration.
* Market access and regulatory consulting throughout the product lifecycle.
* In-country representation and local distributor authorization.
* Post-market surveillance support and correspondence with authorities.
* Translation services for required submission documents.
* Support for modifications and annual renewals.
* Regulatory intelligence and news through their global database and AI tools.
**Reputation / proof points**
* Operates with over 15 offices on five continents.
* Focuses on transparency, accountability, and ethical standards in client relationships.
Additional information
Pure Global offers 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 dossier compilation, in-country representation, translation, modifications, distributor authorization, and post-market support. Buyers can utilize their Fee Calculator for an instant estimate. Their approach emphasizes accelerating market entry by simplifying the regulatory process through AI-driven tools and local expertise.
Key Highlights
-
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.”
-
Provides streamlined registration, local representation, and post-market support.
Source
“Pure Global offers AI-powered medical device regulatory consulting and market access services in over 30 markets.”
-
Transparent, flat-fee pricing starts at $2,000 USD per year per device (excluding government fees).
Source
“Starting at $2,000 USD per year for the first device (excluding government fees).”
-
Supports regulatory compliance and market access in over 30 global 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.”
Certifications & Trust Signals
-
Established presence with 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”
-
Emphasizes ethical standards, transparency, and accountability in client relationships.
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.”
Buyer Snapshot
Best for
- MedTech companies seeking streamlined global market access.
- Businesses requiring AI-powered regulatory consulting and local representation.
How engagement typically works
- Flat-fee annual pricing model.
- AI-driven solutions for efficiency.
- Transparent and accountable partnership.
Typical deliverables
- Dossier compilation and submission.
- In-country regulatory representation.
- Post-market surveillance support.
- Translation of submission documents.
- Distributor authorization.
Good to know
- Best when seeking predictable, flat-fee pricing for regulatory services.
- Suitable for companies needing support in over 30 global markets.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: $2,000 - $4,000 USD per year
Notes:
Based on publicly listed information; final fees depend on scope and number of devices. Excludes government fees.
“Starting at $2,000 USD per year for the first device (excluding government fees).”
HQ:
Boston, UK
Languages:
English
Timezones:
Europe/London
Claim status:
Listed
Services & Capabilities
Find 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
Onboarding involves dossier compilation, in-country representation setup, translation services, and distributor authorization where applicable.
⚡ Instant booking available
Appoint a UK Responsible Person for UKCA Medical Devices
Compare Pure Global (UKRP) and other vetted providers — instant pricing, no RFQ needed.
