Healthcare

Pure Global

AI-powered regulatory consulting for medical device companies seeking market access in over 30 countries.

pureglobal.com

Verified

Quick facts
What is it	AI-powered regulatory consulting for medical device companies seeking market access in over 30 countries.
Pricing	Paid
Free tier	No
Platform	Web Application
Best for	navigating FDA and international regulatory submissions, managing post-market surveillance compliance
Domain registered	2004

Data updated Aug. 1, 2026

What does Pure Global do?

Pure Global provides AI-powered regulatory consulting services specifically for medical device companies. The core function is to help manufacturers navigate the complex process of getting medical devices approved and maintaining compliance across international markets. They combine human expertise with artificial intelligence and data analytics to streamline regulatory submissions and post-market surveillance for more than 30 countries worldwide.

What sets Pure Global apart is their combination of real-world regulatory experience with proprietary AI and data tools. Their GRIP platform appears to be a central component, offering clients a way to manage their regulatory projects and track progress. The service covers the entire lifecycle from initial market access strategy through ongoing compliance, with a team distributed across five continents to provide local expertise.

This service is particularly valuable for medical device companies looking to expand internationally, regulatory affairs professionals managing multiple market submissions, and healthtech startups needing guidance through complex compliance requirements. Real-world applications include helping a company prepare FDA submissions while simultaneously planning European MDR compliance, or managing post-market surveillance reporting across dozens of countries where their devices are sold.

Healthcare Healthcare — Other

#ai consulting#global expansion#healthcare ai#market access#medical devices#regulatory compliance

Key features

What makes it stand out

AI and data tools for regulatory strategy and submissions

Expert consulting for medical device registrations in 30+ markets

Ongoing post-market compliance and surveillance support

Global team with 15+ offices across five continents

Proprietary GRIP platform for project management and tracking

Who is Pure Global for?

Who benefits most from this tool

navigating FDA and international regulatory submissions

managing post-market surveillance compliance

expanding medical devices into new global markets

Pricing

Standard Medical Device Registration

$166.67/month billed yearly

1-10 standard device listings
low/medium or medium/high device risk level
Dossier preparation and submission
In-country representation
Translation services
Modifications and renewals
Importer authorization
Post-market support

EU Registration

$166.67/month billed yearly

1-5 device groups
Ongoing regulatory representation under EU MDR or IVDR
Review of prepared documentation
EUDAMED registration and maintenance
Free Sale Certificate requests

US Registration

$83.33/month billed yearly

Representation as Official Correspondent and US Agent
FDA establishment registration support
Guidance on FDA annual user fee processing

Trust & presence

Domain Domain registered 2004

Gallery

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Pure Global — pricing page — Pricing page

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