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Pure Global

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AI-assisted medical-device regulatory consultancy offering in-country representation and dossier submission across 30+ markets.

What it does

Pure Global is a medical-device regulatory consulting firm that combines in-country representation with AI-assisted regulatory execution. It helps manufacturers register devices and gain market access across more than 30 countries in Asia, Europe, and the Americas for a flat annual fee. Services include dossier compilation and submission, translation, distributor authorization, modifications, and post-market support, plus free MedTech databases and a fee calculator.

How to use: Explore the website to access regulatory updates, insights, and success stories. Use the AI & Data Tools for regulatory research. Contact them for consulting services and market access support.

Core features

AI-assisted regulatory dossier compilation
Local representation across 30+ markets
Translation and distributor authorization
Post-market surveillance support
Instant fee calculator estimates
Free MedTech regulatory databases

Best for

→Registering medical devices in new countries
→Appointing in-country representation
→Estimating registration costs upfront
→Maintaining post-market regulatory compliance

Pricing

First device: from
$2,000
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