Pure Global
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About
Pure Global (formerly PureFDA) is an AI-powered medical device regulatory consulting company. They offer services such as market access, clinical services, and AI & data tools, including the Pure Global Resource Center (formerly GRIP), a global database and AI-powered regulatory tool. They track medical device regulatory trends globally to offer expert analysis and detailed data on millions of products, including product classification, standards, catalog details, and essential specifications across 30 regions.
Platform
Features
• ai solutions
• clinical data comparison
• document search streamlining
• global regulatory news aggregation
• ai-powered research tools
FAQs
What is the advantage of choosing Pure Global as my in-country representative over a commercial distributor?
In most markets, the in-country representative is the legal name on your registration. If your distributor is your representative, conflicts of interest can arise if you want to change or add distributors in that market.
How do I stay up to date on global regulatory changes?
Medical device compliance requirements are constantly evolving. Medical device regulatory consultants at Pure Global actively monitor and analyze developments in 30+ markets.
What is the best stage to seek medical device regulatory consulting services?
As soon as possible. regulatory expertise can be invaluable as early as the device design and development stages. Early regulatory planning can save you time and money long term and facilitate your device’s entry to the market.
Can Pure Global support our entry to multiple markets?
Pure Global delivers end-to-end, on-the-ground in-country representative and medical device regulatory consulting services in the world’s biggest markets .
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