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-powered regulatory consulting and local representation to facilitate market access in over 30 markets.
**Expertise & scope**
* AI-powered dossier compilation and submission to local authorities.
* In-country regulatory representation and local distributor authorization.
* Translation services for required submission documents.
* Post-approval modifications and annual renewals.
* Post-market surveillance correspondence with authorities.
* Support for EU MDR and IVDR compliance, including Post-Market Surveillance (PMS) planning and implementation.
* Global market research, classification, and pathway strategy.
**Reputation / proof points**
* Operates with a focus on honesty, quality, collaboration, and customer needs.
* Has a global footprint with offices across continents.
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.
**Expertise & scope**
* AI-powered dossier compilation and submission to local authorities.
* In-country regulatory representation and local distributor authorization.
* Translation services for required submission documents.
* Post-approval modifications and annual renewals.
* Post-market surveillance correspondence with authorities.
* Support for EU MDR and IVDR compliance, including Post-Market Surveillance (PMS) planning and implementation.
* Global market research, classification, and pathway strategy.
**Reputation / proof points**
* Operates with a focus on honesty, quality, collaboration, and customer needs.
* Has a global footprint with offices across 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 is designed to provide predictable costs for regulatory consulting and representation. Their services are AI-driven, aiming to accelerate the market entry process for medical device manufacturers. They emphasize transparency in their pricing and offer comprehensive support that includes dossier preparation, in-country representation, translations, modifications, distributor authorization, and post-market support.
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 flat-fee services 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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Covers EU MDR and IVDR Post-Market Surveillance (PMS) requirements.
Source
“The EU Directives as well as the EU Regulations, the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Devices Regulation (EU) 2017/746 (IVDR), require manufacturers and other economic operators to plan, implement, and maintain a Post-Market Surveillance system.”
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Facilitates market entry in over 30 global markets.
Source
“Pure Global offers local representation and registration services across more than 30 markets through our extensive network of local entities and trusted partners.”
Certifications & Trust Signals
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Emphasizes trust, 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
- Medical device manufacturers seeking EU Authorized Representative services.
- Companies looking to accelerate market entry into the EU and other global markets.
- Businesses requiring AI-driven regulatory consulting and local representation.
How engagement typically works
- Flat-fee annual service model.
- AI-powered solutions for efficiency.
- Partnership approach to regulatory compliance.
Typical deliverables
- EU Authorized Representative services.
- Dossier compilation and submission.
- In-country representation.
- Post-market surveillance support.
- Regulatory strategy and pathway development.
Good to know
- Best when seeking predictable, flat-fee pricing for regulatory services.
- Ideal for companies prioritizing AI-driven efficiency in market access.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: Starting at $2,000 USD per year for the first 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 (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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