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
**Who they are**
Pure Global (EU Authorized Representative) is a global growth partner for MedTech companies, leveraging AI and data to deliver efficient market access solutions. They combine domain expertise with transformative technology to help clients expand their global reach.
**Expertise & scope**
* AI-powered regulatory consulting and local representation for medical device market access.
* Services include dossier compilation, in-country representation, translation, modifications, distributor authorization, and post-market support.
* Coverage across more than 30 markets globally.
* Specialized support for EU MDR and IVDR Post-Market Surveillance (PMS).
**Reputation / proof points**
* Operates with a focus on honesty, quality, collaboration, and customer needs.
* Has over 15 offices on five continents.
Pure Global (EU Authorized Representative) is a global growth partner for MedTech companies, leveraging AI and data to deliver efficient market access solutions. They combine domain expertise with transformative technology to help clients expand their global reach.
**Expertise & scope**
* AI-powered regulatory consulting and local representation for medical device market access.
* Services include dossier compilation, in-country representation, translation, modifications, distributor authorization, and post-market support.
* Coverage across more than 30 markets globally.
* Specialized support for EU MDR and IVDR Post-Market Surveillance (PMS).
**Reputation / proof points**
* Operates with a focus on honesty, quality, collaboration, and customer needs.
* Has over 15 offices on five continents.
Additional information
Pure Global offers a flat-fee annual service for market entry, starting at $2,000 USD per year for the first device (excluding government fees). This pricing model aims to provide predictable costs for regulatory consulting and local representation. Their AI-powered tools and extensive network of local entities and partners are designed to streamline the market access process, minimize application rejections, and reduce overall costs for medical device manufacturers seeking to enter new markets.
Key Highlights
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Offers AI-powered regulatory consulting and local representation for medical device market access.
Source
“Pure Global offers AI-powered regulatory consulting and local representation for medical device market access in over 30 markets.”
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Provides comprehensive services including dossier compilation, in-country representation, and post-market support.
Source
“Includes dossier submission, in-country representation, translation, modifications, distributor authorization, and post-market support.”
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Operates with a flat-fee annual pricing 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 (excludes government fees).”
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Has a global 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”
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Specializes in EU MDR and IVDR Post-Market Surveillance (PMS) requirements.
Source
“EU MDR and IVDR Postmarket Surveillance (PMS); PMS requirements for medical devices and IVDs in the EU”
Certifications & Trust Signals
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Founded in 2010, Pure Global has extensive experience in the MedTech regulatory space.
Source
“From launching AI-driven regulatory solutions to expanding our global footprint, it was a year of meaningful milestones and shared moments.”
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Emphasizes trust, honesty, and ethical standards in client relationships.
Source
“Trust is the cornerstone of our relationships with customers, employees, and partners. We uphold the highest ethical standards”
Buyer Snapshot
Best for
- Medical device manufacturers seeking EU Authorized Representative services.
- Companies looking to accelerate market entry into the EU and other global markets.
- Businesses prioritizing AI-driven regulatory solutions and flat-fee pricing.
How engagement typically works
- AI-powered consulting and local representation.
- Flat-fee annual service model.
- Partnership approach to regulatory compliance.
Typical deliverables
- EU Authorized Representative services.
- Dossier compilation and submission.
- In-country representation.
- Post-market surveillance support.
- Translation services.
Good to know
- Best when clients require support for medical device market access.
- Best when clients are comfortable with AI-driven solutions and flat-fee structures.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: Starting at $2,000 USD per year for the first device (excluding government fees)
Notes:
Based on publicly listed information; final fees depend on scope and additional devices.
“Starting at $2,000 USD per year for the first device (excludes government fees).”
HQ:
Boston, Canada
Languages:
English
Timezones:
America/New_York
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.
