Pure Global MedTech
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Introduction
Medical device regulatory consulting with AI
Pure Global MedTech Product Information
Pure Global | AI-Powered Medical Device Regulatory Consulting
Pure Global is a global medical device regulatory consulting firm that combines real-world experience with AI and data to help medtech companies achieve rapid market access. With 15+ offices across five continents, they offer real-time, ongoing regulatory support for registrations, post-market compliance, and strategic market entry across 30+ markets.
Key offering
- End-to-end regulatory consulting for medical devices and in vitro diagnostics throughout the product lifecycle
- In-country representation and local-market insight to streamline registrations and compliance
- AI-powered regulatory insights and real-time market data to inform decisions
- Global market access support across diverse regulatory environments
How it works
- Leverage global regulatory data and AI-driven insights to map your device’s regulatory pathway across target markets.
- Engage Pure Global’s regulatory experts to prepare submissions, regulatory strategies, and post-market activities.
- Utilize their local representation capabilities to manage registrations, submissions, and local compliance requirements.
- Monitor regulatory changes in 30+ markets to keep your product up-to-date and compliant.
Markets and reach
- 30+ markets covered
- 15+ offices across the United States, Europe, UK, Asia, Latin America, and Australia
- In-country representation in key markets to ensure proper legal naming on registrations and proactive local support
Countries and regions listed on their site include (non-exhaustive): United States, Canada, European Union, United Kingdom, Switzerland, Mexico, Brazil, Argentina, Israel, UAE, China, Singapore, India, Japan, Australia, and many more. They partner with local firms to extend reach into South Asia, the Middle East, Africa, and beyond.
Services
- Market Access Strategy and Market Entry Planning
- Regulatory Submissions and Approvals (global)
- Regulatory Compliance Management (QMS alignment, post-market)
- Local Representation and In-Country Registration
- Clinical Services and Evidence Planning
- Lifecycle Management, including post-market surveillance and extensions
- In-depth Regulatory Change Monitoring across 30+ markets
- Training, Market Analysis, and tailored capacity building
Resources & Tools
- GRIP Platform: AI-powered regulatory update tool
- Regulatory Center: Real-time regulatory changes and analysis
- Blog and Newsletter: Expert insights and updates
- Community and Events: Networking and knowledge sharing
Why choose Pure Global
- Global scale with local regulatory expertise across markets
- AI-assisted data to accelerate registrations and reduce time-to-market
- Proactive regulatory monitoring to help you stay compliant
- Flexible engagement models—from startup to multinational corporations
How to engage
- Contact a global medical device regulatory consultant
- Request information or a discovery call
- Start with early regulatory planning to align design, indications for use, and QMS requirements
Core Features
- Global regulatory coverage across 30+ markets
- In-country representation with local regulatory authority engagement
- AI-powered regulatory insights and real-time market data
- End-to-end regulatory services from market access to post-market compliance
- Clinical services and evidence planning support
- Lifecycle management and ongoing regulatory monitoring
- Comprehensive training and market analysis offerings