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 trusted global growth partner for MedTech companies, delivering smart and efficient market access solutions powered by transformative data, technology, and high-quality domain expertise. They combine real-world experience with AI and data to build efficient medical device regulatory consulting solutions.

**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, including the European Union.
* Specialized support for EU MDR and IVDR Post-Market Surveillance (PMS) requirements.
* Offers a Global Regulatory Intelligence Platform (GRIP) for accessing regulatory news, streamlining document searches, and comparing clinical research data.

**Reputation / proof points**
* Operates with a focus on honesty, quality, collaboration, customer needs, and initiative.
* Emphasizes trust as the cornerstone of relationships, upholding high ethical standards and transparency.

Additional information

Pure Global offers a flat-fee service model for market entry, starting at $2,000 USD per year for the first device (excluding government fees). This pricing typically includes dossier submission, in-country representation, translation services, modifications, distributor authorization, and post-market support. Their AI-driven approach aims to accelerate market entry and streamline regulatory compliance efforts, minimizing application rejections and reducing costs. They provide access to a global database and AI-powered tools for regulatory research and news.

Key Highlights

  • 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.”
  • Provides a flat-fee service 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).”
  • Covers market access in over 30 markets globally. Source
    “We combine real-world experience with AI and data to build smart, efficient medical device regulatory consulting solutions for more than 30 markets.”
  • Specializes in EU MDR and IVDR Post-Market Surveillance (PMS) requirements. Source
    “EU MDR and IVDR Postmarket Surveillance (PMS)”

Certifications & Trust Signals

  • Emphasizes trust, high ethical standards, and transparency 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.”
  • Leverages AI and data for smart, efficient market access solutions. 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.”

Buyer Snapshot

Best for
  • MedTech companies seeking to accelerate market entry in the EU and other global markets.
  • Companies requiring AI-powered regulatory consulting and local representation.
  • Manufacturers needing support with EU MDR and IVDR Post-Market Surveillance.
How engagement typically works
  • Flat-fee annual service model.
  • Partnership approach to streamline market access.
  • Leverages AI and data for efficient solutions.
Typical deliverables
  • Dossier compilation and submission.
  • In-country representation.
  • Translation services.
  • Post-market surveillance support.
  • Regulatory intelligence and news.
Good to know
  • Best when seeking predictable, flat-fee pricing for regulatory services.
  • Ideal for companies prioritizing AI-driven efficiency in regulatory processes.
  • Requires clear definition of device scope for accurate pricing.

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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