Pure Global (EU Authorized Representative)
Pure Global
Pure Global offers AI-powered regulatory consulting and local representation for medical device market access in over 30 markets. Accelerate your entry with their flat-fee services.
Pure Global specializes in accelerating market entry for MedTech companies through AI-powered regulatory consulting and local representation. With a global footprint spanning over 15 offices across five continents, they provide real-time, ongoing support for medical device registrations and post-market compliance. Their services include AI-driven dossier compilation, in-country representation, translation, modifications, distributor authorization, and post-market support, all offered under a transparent, flat annual fee starting at $2,000 USD per device. This comprehensive approach aims to streamline the regulatory process, minimize application rejections, and reduce unnecessary costs. Pure Global leverages real-world experience with AI and data to build efficient regulatory solutions. They assist in identifying target markets, determining product classification, and outlining the necessary steps for registration. Their Global Regulatory Intelligence Platform provides access to global regulatory news, document searches, clinical research data, and AI-powered research tools to support compliance journeys. They offer a one-stop solution for international registration, ensuring devices meet the requirements of over 30 markets. Whether you are seeking initial information or ready to partner, Pure Global guides you through every step of the regulatory process.
About
Pure Global (EU Authorized Representative) is a global growth partner for MedTech companies, leveraging AI-powered regulatory consulting and local representation to facilitate market access in over 30 markets. They specialize in accelerating entry through streamlined processes and transparent, flat-fee services.
**Expertise & Scope**
* AI-powered dossier compilation and submission to local authorities.
* In-country regulatory representation and local entity establishment.
* Translation services for required submission documents.
* Support for modifications, annual renewals, and post-market surveillance correspondence.
* Distributor authorization and importation handling.
* Expertise in EU MDR and IVDR Post-Market Surveillance (PMS) requirements.
**Reputation / Proof Points**
* Operates in over 30 markets globally.
* Offers services across Europe, including EU MDR and IVDR consulting.
**Expertise & Scope**
* AI-powered dossier compilation and submission to local authorities.
* In-country regulatory representation and local entity establishment.
* Translation services for required submission documents.
* Support for modifications, annual renewals, and post-market surveillance correspondence.
* Distributor authorization and importation handling.
* Expertise in EU MDR and IVDR Post-Market Surveillance (PMS) requirements.
**Reputation / Proof Points**
* Operates in over 30 markets globally.
* Offers services across Europe, including EU MDR and IVDR consulting.
Additional information
Pure Global emphasizes a flat-fee annual model for its services, starting at $2,000 USD per year for the first device, excluding government fees. This predictable pricing structure aims to simplify budgeting for market entry. Their services are designed to be comprehensive, covering dossier preparation, in-country representation, translation, and ongoing post-market support. Buyers should note that government and third-party fees are separate from their listed service fees. Engagement typically involves leveraging their AI tools for dossier compilation and utilizing their network for local representation.
Key Highlights
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Pure Global provides AI-powered regulatory consulting and local representation for medical device market access.
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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Offers services in over 30 markets, including comprehensive EU MDR and IVDR support.
Source
“Pure Global offers local representation and registration services across more than 30 markets through our extensive network of local entities and trusted partners.”
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Provides a flat-fee service model starting 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). Includes dossier submission, in-country representation, translation, modifications, distributor authorization, and post-market support.”
Certifications & Trust Signals
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Established presence with offices across continents and a network of local entities.
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.”
Buyer Snapshot
Best for
- MedTech companies seeking to accelerate EU market entry.
- Companies requiring local representation and regulatory compliance support in multiple global markets.
- Businesses looking for predictable, flat-fee regulatory services.
How engagement typically works
- AI-driven regulatory consulting.
- Local representation through established networks.
- Partnership for streamlined market access.
Typical deliverables
- Compiled regulatory dossiers.
- In-country representation agreements.
- Submission packages for authorities.
- Post-market surveillance reports.
- Translated regulatory documents.
Good to know
- Best when a flat-fee, predictable cost structure is preferred.
- Requires clear definition of device scope for accurate initial pricing.
- Government and third-party fees are additional.
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/third-party fees.
“Starting at $2,000 USD per year for the first device (excludes government fees).”
HQ:
Boston, Canada
Languages:
English
Timezones:
America/New_York
Claim status:
Listed
Services & Capabilities
Best EU Authorized Rep (EC REP) | Compare & Get Quotes
Jurisdictions:
EU
Countries:
IE, DE, FR, NL, BE, ES
Industries:
Medical devices, IVD, Healthcare
Portfolio:
26-100, 100+
Onboarding time:
3–21 days
Pricing model:
Custom pricing
Starting from:
EUR 8,500
Included services:
EU Authorized Representative (EC REP) designation, Authority liaison and document availability support, Vigilance escalation and FSCA coordination, Labeling/EC REP identification review, Post-market support workflows (complaints, vigilance escalation)
Supports MDR:
Yes
Supports IVDR:
Yes
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
Post Market Support:
Yes
Labeling Review:
Yes
EU Entity Country:
NL
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Alternate Names:
Pure Global
Fsca Recall Support:
Yes
510k_submission_services
Additional eu_ar Details
Supports MDR
Yes
Supports IVDR
Yes
Fsca Recall Support
Yes
Post Market Support
Yes
Vigilance Contact Support
Yes
Onboarding Steps
Onboarding involves dossier compilation, in-country representation setup, translation, and submission to local authorities.
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