Pure Global

Pure Global offers AI-powered medical device regulatory consulting, accelerating market entry with global expertise and local representation for over 30 markets.

Pure Global provides AI-driven regulatory solutions and consulting services for medical device companies aiming to navigate global markets. With over 15 offices across five continents, their team of experts offers real-time regulatory support for device registrations and post-market compliance. They specialize in accelerating market entry through AI-powered dossier compilation and local representation, offering services for a flat annual fee starting at $2,000 USD per year for the first device. This includes dossier submission, in-country representation, translation, modifications, distributor authorization, and post-market support. Pure Global leverages real-world experience with AI and data to build smart, efficient solutions for over 30 markets, helping clients overcome regulatory challenges and begin selling in their target markets faster. They also provide resources like weekly regulatory news, a regulatory blog, and AI-powered update tools to keep clients informed.

About

**Who they are**
Pure Global is a medical device regulatory consulting firm specializing in AI-powered solutions to accelerate market entry. They leverage global expertise with local representation across numerous markets.

**Expertise & scope**
* AI-powered medical device regulatory consulting
* Market entry acceleration
* Global expertise and local representation
* Coverage for over 30 markets

**Reputation / proof points**
* US coverage

Additional information

Pure Global focuses on streamlining the market access process for medical devices through advanced AI technology. Their approach combines broad international regulatory knowledge with on-the-ground presence in key regions, aiming to reduce time-to-market for their clients. Buyers can expect a strategic partnership focused on navigating complex global regulatory landscapes.

Key Highlights

  • Offers AI-powered medical device regulatory consulting. Source
    “Pure Global offers AI-powered medical device regulatory consulting”
  • Accelerates market entry with global expertise and local representation. Source
    “accelerating market entry with global expertise and local representation”
  • Provides coverage for over 30 markets. Source
    “for over 30 markets”
  • Offers services in English. Source
    “Languages: English”

Certifications & Trust Signals

  • Covers the US market. Source
    “Coverage: US”
  • Services are available in English. Source
    “Languages: English”

Buyer Snapshot

Best for
  • Medical device companies seeking to accelerate global market entry
  • Firms needing AI-driven regulatory consulting
How engagement typically works
  • Strategic partnership
  • Leveraging global and local expertise
Typical deliverables
  • Market access strategies
  • Regulatory compliance guidance
  • AI-powered consulting solutions
Good to know
  • Best when requiring support across multiple global markets
HQ: United States, Canada
Languages: English
Timezones: EST, PST
Status: listed

Services & Capabilities

FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment)

Jurisdictions: US
Countries: US
Industries: Medical Devices, IVD
Onboarding time: 7–21 days
Pricing model: Custom pricing
Service Types: Mock FDA Inspection
Earliest Start: flexible
Delivery Mode: Hybrid
Inspection Experience: Former FDA investigator on team

Additional fda_qmsr_transition_inspection_readiness Details

Service Types
QMSR/ISO 13485 Gap Assessment, SOP/Documentation Remediation, Design Controls/DHF Modernization, CAPA & Nonconformance Remediation, Supplier Controls/Quality Agreements, Internal Audit Program Upgrade, Mock FDA Inspection, Training & Competency Programs, 483 Response & Remediation Support
Earliest Start
flexible
Delivery Mode
Hybrid
Inspection Experience
Supports mock inspections regularly
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