AI-Powered Medical Device Registration Made Simple: Outperform Freyr with Pure Innovation
Navigate Global Market Access and Regulatory Compliance with Smart Solutions that Combine Real-World Expertise and AI Technology
Transform your regulatory journey with intelligent tools built for today's medical device challenges
Experience AI-Powered ComplianceCompare Medical Device Regulatory Solutions
See how our AI-powered platform transforms the regulatory process compared to traditional consulting approaches
AI-Powered Medical Device Regulatory Navigation
Intelligent compliance tools with global expertise
Navigate the complex world of medical device regulations with our cutting-edge AI-powered platform. Track real-time regulatory changes across 30+ markets, access millions of registered products, and leverage smart tools for classification and compliance. Our solution combines artificial intelligence with deep regulatory expertise to streamline your path to market.
Traditional Medical Device Consulting
Conventional regulatory services
A established player in medical device regulatory consulting, Freyr offers comprehensive services across global markets. With expertise in device registration, classification, and market access, they provide traditional consulting support backed by a team of 2100+ regulatory experts and presence in 120+ countries.
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Pure Global vs Freyr: Medical Device Regulatory Solutions Comparison
Compare key features to see why our AI-powered approach delivers superior results
| Feature | Pure Global | Freyr |
|---|---|---|
| AI-Powered Regulatory Tools | ✓ | ✗ |
| Global Market Coverage | 30+ markets with direct local presence | Limited direct presence, relies more on partnerships |
| Regulatory Database Access | 5M+ registered products, 600K+ standards tracked | Basic regulatory database |
| Dedicated Resource Center | ✓ | ✗ |
| Real-time Regulatory Updates | ✓ | ✓ |
| Clinical Services Coverage | Clinical sites across US, Europe, and Africa | Limited clinical service locations |
| Post-Market Surveillance | ✓ | ✓ |
| SaMD Expertise | Comprehensive AI/ML device expertise with dedicated solutions | Basic SaMD registration support |
| Free Trial Option | ✓ | ✗ |
| Quality Management System Support | ✓ | ✓ |
Accelerate Global Market Access with AI-Powered Regulatory Intelligence
Navigate complex medical device regulations with our comprehensive platform combining real-world expertise and advanced AI technology across 30+ markets worldwide.
Smart Regulatory Navigation
AI-powered tools and real-time database access help streamline device registration processes, reducing approval timelines while ensuring compliance across multiple markets.
Global Market Coverage
Access regulatory expertise for 30+ markets through our network of local offices and representatives, enabling seamless market entry from Americas to Asia-Pacific.
Proven Track Record
Over 2500 successful global registration certificates, 99% first-time-right submission rate, and comprehensive support for all device risk classifications.
End-to-End Support
From initial strategy through post-market surveillance, our platform combines regulatory consulting, documentation management, and compliance monitoring in one solution.
Why Pure Global Leads Medical Device Compliance
Navigate the complex world of medical device regulatory compliance with confidence. Our AI-powered solutions and global expertise make us the smarter choice for your regulatory journey.
AI-Powered Intelligence & Real-Time Updates
Our innovative AI technology tracks regulatory changes across 30+ markets in real-time, analyzing millions of registered products. This means you're always ahead of compliance requirements, with smart tools that turn complex regulatory data into actionable insights for faster market access.
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Global Reach with Local Expertise
With over 15 offices across five continents and proven success in 30+ markets, we offer true global coverage with deep local knowledge. Our team of regulatory experts provides real-time support for medical device registrations and maintains post-market compliance wherever you need to be.
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Proven Track Record of Success
Our numbers speak volumes: 500+ satisfied clients globally, 2500+ successful registration certificates, and a remarkable 99%+ first-time-right submission rate. We combine strategic regulatory guidance with efficient processes to get your medical devices to market faster.
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Frequently Asked Questions
We maintain control of your registration, fulfill all regulatory obligations professionally, and provide expert guidance. Unlike distributors, we have no conflicts of interest and specialize in regulatory requirements across 30+ markets.
We provide end-to-end support in major markets worldwide through offices in the US, Europe, UK, Asia, Latin America, and Australia. Through partnerships, we extend coverage to South Asia, Middle East, and Africa.
The earlier, the better! Starting during device design and development helps us plan regulatory strategies, establish compliant QMS, identify testing needs, and gather clinical data - saving you time and money.
We offer Weekly Regulatory News updates, an in-depth regulatory blog, and an AI-powered update tool. Plus, our experts actively monitor and analyze developments across 30+ markets to keep you informed.
Our AI-powered database tracks regulatory trends in 100+ countries, offering expert analysis and detailed data on millions of products, including classifications, standards, and specifications across 30 regions.
Yes! We offer scalable solutions for everyone - from agile guidance for startups to strategic support for global scalups and comprehensive regulatory strategies for multinational enterprises.
Unlock Global MedTech Markets with AI-Powered Regulatory Excellence
Navigate 30+ markets faster with our smart regulatory solutions backed by real-time data and expert consulting.
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