Pure Global

Pure Global is an AI-powered medical device regulatory consulting tool that provides smart and efficient solutions for market access and compliance. It offers global registration services and post-market support for medical devices.

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At a glance

Pricing

Paid

Free tier

API

Skill level

Technical

About

What is Pure Global?

Pure Global offers AI-powered medical device regulatory consulting, providing smart and efficient solutions for market access and regulatory compliance. The platform leverages AI and data to streamline dossier compilation and offers local representation across over 30 countries. Services include market registration, regulatory strategy development, quality assurance, and local representation. Pure Global supports medical device and in vitro diagnostics manufacturers of all sizes, from startups to multinational enterprises, helping them navigate complex international regulations. Their offerings include assistance with registrations in numerous markets such as the US (FDA), EU (MDR/IVDR), Canada (CDMR), and many countries in South America, Asia Pacific, and the Middle East/Africa. They also provide clinical services and AI & Data tools for research and regulatory insights.

Best used for

Ideal for medical device manufacturers and life sciences companies who need to navigate complex global regulatory landscapes, secure market approvals, and maintain compliance. Especially valuable for accelerating market entry with AI-powered dossier compilation and local representation in diverse international markets.

Common actions

ensure regulatory compliance

accelerate market entry

manage medical device registration

develop regulatory strategies

Capabilities

Key features

AI-powered dossier compilation
Local representation (30+ countries)
Medical device registration
Regulatory strategy development
Quality assurance processes
Post-market support

Target Audience

regulatory affairs managersmedical device manufacturersquality assurance professionalsstartup founders in medtech

Integrations

Not yet documented

Pricing & Plans

Paid

Not publicly disclosed. Check pureglobal.com for current pricing.

FAQs

What is the starting price for Pure Global's services?

Pure Global's services start at $2,000 USD per year for the first medical device. This fee covers dossier submission, in-country representation, translation, modifications, distributor authorization, and post-market support, excluding government fees.

Which markets does Pure Global cover for medical device registration?

Pure Global offers medical device registration and compliance services across more than 30 markets. This includes major regions like the US, EU, Canada, and countries in South America, Asia Pacific, and the Middle East/Africa.

How does Pure Global use AI in its regulatory consulting?

Pure Global utilizes AI and data tools to power efficient solutions such as dossier compilation, aggregating global regulatory news, streamlining document searches, and comparing clinical data. This helps accelerate market entry and ensures compliance.

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