Pure Global
Accelerate medical device approvals across global markets
Overview
Pure Global combines AI-powered tools with regulatory expertise to help medical device companies navigate complex international compliance requirements. Their platform streamlines market entry processes across 30+ countries while maintaining control over device registrations. Offers ongoing support for post-market compliance and regulatory updates.
Key Features
GRIP Platform
AI-powered regulatory intelligence and workflow management
Global Network
15+ offices with local regulatory experts worldwide
Multi-Market Support
End-to-end registration in 30+ medical device markets
Regulatory Monitoring
Weekly updates on global compliance changes
Use Cases
Enter new international medical markets
Streamline regulatory submissions
Track compliance changes in 30+ countries
Prepare clinical data for approvals
Pros & Cons
Pros
- Combines AI tools with human regulatory expertise
- Maintains control of device registrations vs using distributors
- Proactive regulatory change monitoring
- Single source for multi-market compliance
Cons
- Specialized focus only on medical devices (not pharma/diagnostics)
- Custom pricing may be prohibitive for startups
Frequently Asked Questions
Why choose Pure Global over a commercial distributor?
Maintains direct control of your registrations while providing expert regulatory guidance and conflict-free representation
How to stay updated on regulatory changes?
Use their weekly news updates, regulatory blog, and AI-powered monitoring through the GRIP platform
When should companies engage regulatory consultants?
Early in device development to optimize compliance planning and avoid costly revisions
Reviews for Pure Global
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