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 regulatory consulting for medical devices
* Market entry acceleration
* Global expertise and local representation
* Support for over 30 markets
* Focus on US coverage

**Reputation / proof points**
* Founded in 2019

Additional information

Pure Global's approach integrates artificial intelligence to streamline the complex process of medical device regulatory consulting. Their service model is designed to expedite market access by combining broad international knowledge with on-the-ground presence in key regions. This dual approach ensures that clients can navigate diverse regulatory landscapes efficiently. The company's focus on the US market, coupled with its extensive global network, positions it to assist manufacturers in achieving compliance and launching products effectively.

Key Highlights

  • Offers AI-powered medical device regulatory consulting. Source
    “Pure Global offers AI-powered medical device regulatory consulting”
  • Accelerates market entry for medical devices. Source
    “accelerating market entry”
  • Provides global expertise with local representation. Source
    “global expertise and local representation”
  • Covers over 30 markets. Source
    “for over 30 markets”
  • Focuses on US market coverage. Source
    “Coverage: US”

Certifications & Trust Signals

  • Founded in 2019. Source
    “Founded in 2019”

Buyer Snapshot

Best for
  • Medical device manufacturers seeking to accelerate market entry
  • Companies needing global regulatory expertise with local market insights
  • Businesses requiring AI-driven consulting solutions
How engagement typically works
  • Project-based consulting
  • Strategic advisory services
  • Global market access support
Typical deliverables
  • Market entry strategy
  • Regulatory compliance guidance
  • Global market representation
Good to know
  • Best when requiring support for over 30 markets
  • Best when US market entry is a primary objective
HQ: United States, Canada
Languages: English
Timezones: EST, PST
Claim 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: QMSR/ISO 13485 Gap Assessment, Mock FDA Inspection, 483 Response & Remediation Support
Earliest Start: flexible
Delivery Mode: Hybrid
Inspection Experience: Former FDA investigator on team, Supports mock inspections regularly, ISO 13485 lead auditor capability

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
Request quotes
Cruxi - Regulatory Compliance Services