Pure Global
Pure Global provides comprehensive solutions designed to meet regulatory compliance and market access requirements for MedTech companies. L...
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What is Pure Global?
Pure Global is an AI-powered medical device regulatory consulting firm that provides end-to-end solutions for MedTech companies seeking global market access. They combine advanced AI tools, deep regulatory expertise, and in-country presence across over 25 countries to handle everything from product registration and clinical trials to post-market surveillance and quality assurance. With offices in 15+ locations on five continents, Pure Global acts as a one-stop partner, streamlining complex regulatory processes through their GRIP platform and other data-driven tools.
Key features include AI-assisted dossier compilation, local representation in major markets like the US, EU, China, Brazil, and Japan, comprehensive regulatory strategy consulting, and ongoing compliance support. Their services cover the full product lifecycle, from early development planning to revenue generation post-launch, with a focus on efficiency and cost-effectiveness. They serve startups, scaleups, and multinational enterprises in medical devices and IVDs.
Pure Global is designed for MedTech innovators and manufacturers aiming to expand internationally without navigating regulatory hurdles alone. Their flat-fee model and tech integration make global expansion accessible, backed by ISO 13485 certification and over 2500 successful registrations. They emphasize customer-first values, integrity, and innovation to improve quality of life worldwide.
Pure Global pricing
Pricing model: Free
Simple, transparent flat annual fee starting at $2,000 USD per year for the first device (excludes government fees). Includes AI-powered dossier preparation, submission, in-country representation, translations, modifications, distributor authorizations, and post-market support. Use their Fee Calculator for instant estimates across markets.
Pure Global pros
- AI-powered dossier compilation speeds up submissions
- In-country representation in 25+ countries
- Flat annual fee starting at $2000 per device
- Covers US, EU, China, Brazil, Japan markets
- ISO 13485 certified quality management
- Over 2500 global registration certificates
- 500+ clients served worldwide
- Local offices on five continents
- Post-market surveillance support included
- Clinical trial management services
- Regulatory news and updates monitoring
- Biocompatibility and packaging testing
- Authorized Representative role fulfillment
- GRIP platform for regulatory intelligence
- Tailored solutions for startups and enterprises
- Weekly regulatory news round-ups
- Partnerships for extended market coverage
Pure Global cons
- Excludes government fees from pricing
- Limited to medical devices and IVDs
- Requires early engagement for best results
- Dependent on local regulatory timelines
- Flat fee may not suit single-market needs
- No mention of free tier or trials
- Focus on specific 30+ markets only
- AI tools may need user oversight
- Post-Brexit UK processes still evolving
Frequently asked questions about Pure Global
What is the advantage of choosing Pure Global as my in-country representative over a commercial distributor?
Choosing Pure Global maintains control over your registration as they hold the legal name, avoiding distributor conflicts. They fulfill all regulatory obligations with deep experience, provide expert guidance on dossiers, and act as proactive liaisons with authorities in markets where offered.
How do I stay up to date on global regulatory changes?
Pure Global monitors 30+ markets and offers weekly regulatory news round-ups, in-depth blog analysis, and an AI-powered update tool. Join their community for insights delivered to your inbox on medical device compliance developments.
What is the best stage to seek medical device regulatory consulting services?
As early as device design and development to plan for regulatory implications, establish QMS, identify testing needs, and gather clinical data. Early involvement saves time and money compared to reacting to rejections later.
Can Pure Global support our entry to multiple markets?
Yes, they provide end-to-end services from offices in US, Europe, UK, Asia, Latin America, and Australia, plus partnerships for South Asia, Middle East, Africa. Covers key markets like US FDA, EU CE, China NMPA, Brazil ANVISA.
What services does Pure Global offer for market registration?
They guide through approvals and certifications, create regulatory strategies, handle pre-submission activities, and provide local representation. Includes dossier submission and compliance with authorities in target markets.
How does Pure Global use AI in their services?
AI assists in regulatory document preparation, dossier compilation, aggregating global regulatory news, streamlining searches, and comparing clinical data via tools like GRIP platform on Azure Marketplace.
What markets does Pure Global cover?
Over 25 countries including United States, Canada, EU, UK, Switzerland, Brazil, Argentina, China, Japan, Singapore, India, Australia, Saudi Arabia, UAE, with 15+ offices for real-time support.
Is Pure Global certified for quality management?
Yes, awarded official BSI ISO 13485:2016 certificate, ensuring high standards in regulatory consulting and medical device services.
What is included in Pure Global's flat fee pricing?
AI dossier compilation, submission, in-country rep, translations, modifications, distributor auth, post-market support, excluding only government fees, starting at $2000/year per first device.
Who does Pure Global serve?
Tailored for MedTech startups with agile support, global scaleups for emerging markets, and multinational enterprises for portfolio optimization and regulatory strategies.