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 combined with local representation across numerous markets.
**Expertise & scope**
* AI-powered regulatory consulting for medical devices
* Market entry acceleration
* Global expertise with local representation
* Support for over 30 markets
* Focus on US regulatory landscape
**Reputation / proof points**
* Founded in 2017
Pure Global is a medical device regulatory consulting firm specializing in AI-powered solutions to accelerate market entry. They leverage global expertise combined with local representation across numerous markets.
**Expertise & scope**
* AI-powered regulatory consulting for medical devices
* Market entry acceleration
* Global expertise with local representation
* Support for over 30 markets
* Focus on US regulatory landscape
**Reputation / proof points**
* Founded in 2017
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 providing comprehensive global insights supported by on-the-ground representation in key regions. This dual approach ensures that clients benefit from both broad strategic understanding and localized, practical execution. They cater to a diverse range of medical device clients seeking to navigate international regulatory requirements efficiently.
Key Highlights
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Founded in 2017, Pure Global has been providing regulatory consulting services.
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“Founded in 2017”
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Offers AI-powered medical device regulatory consulting.
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“AI-powered medical device regulatory consulting”
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Provides market entry acceleration with global expertise and local representation.
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“accelerating market entry with global expertise and local representation”
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Supports clients in over 30 markets.
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“for over 30 markets”
Certifications & Trust Signals
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Pure Global focuses on the US market.
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“Coverage: US”
Buyer Snapshot
Best for
- Medical device companies seeking to accelerate global market entry
- Firms needing AI-driven regulatory consulting
How engagement typically works
- Consulting partnership
- Leveraging AI for regulatory processes
Typical deliverables
- Market entry strategy
- Regulatory compliance guidance
- Global market access support
Good to know
- Best when requiring specialized AI-powered regulatory expertise for medical devices.
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
Remote
Inspection Experience
Supports mock inspections regularly
