Unlocking Global Markets For MedTech Companies

We provide smart and efficient solutions to navigate through market access and regulatory compliance requirements powered by AI and Data.

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We streamline access to global markets

Our team of global experts, and local representatives located at Pure Global’s offices across the world, accelerates the process of obtaining and maintaining market access and allows you to focus on commercial success.

Market Access

Reach Your Target Markets Confidently

Having serviced a high volume of clients successfully by obtaining registrations globally, we will support you with successful market access into any target market.

Clients Served Globally
Global Registration Certificates
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Regulatory Experts for Medical Devices and IVDs
Global Regulatory Intelligence Platform

Gain Access To
Regulatory Knowledge

We track regulatory trends in 100+ countries, to offer expert analysis and detailed data on millions of products across 30 regions, including product classification, standards, catalog details, and essential specifications.

Registered Products
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We safeguard your product’s launch and ongoing global compliance.

From regulatory compliance to conquering new markets, our comprehensive solutions are designed to meet every challenge in your journey.

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Market Registration

We guide you through securing approvals and certifications from regulatory bodies, ensuring your product is ready for market entry.

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Regulatory Services

We create efficient strategies for regulatory approval, providing advice on pathways and pre-submission activities.

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Quality Assurance

We guarantee your products meet international quality standards and compliance requirements, both before and after market entry.

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Local Representation

We establish our own operations in key markets worldwide, offering direct insight and support for local compliance and market entry.

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Clinical Services

We offer end-to-end clinical trial management, covering everything from pre-market development to post-market surveillance.

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Other Services

We offer market analysis, lifecycle management, and targeted training to navigate global healthcare markets effectively.

Who can we help?

Our Solutions Are Tailored for emerging entrepreneurs and seasoned professionals

Pure Global provides tailored solutions to medical device and in vitro diagnostics manufacturers of all scales to gain market access.

Consultants, experts in medical device registration and regulations for Startups


Get agile regulatory guidance and cost-effective solutions with our personalized support to quickly market your innovations.

Global Scaleups Regulatory Guidance

Global Scaleups

Expand globally with our strategic support and partnership development to grow beyond your current boundaries.

Regulatory Guidance for Multinational Enterprises

Multinational Enterprise

Use our global regulatory strategies and tech integration, to navigate regulatory complexities and optimize your portfolio.

Don't miss out on
any industry updates

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Latest Blog Content

Explore our collection of articles, success stories, and regulatory updates, designed to help you take your product global.

Blog Article
AI in Medtech Brazil

Artificial intelligence (AI) is revolutionizing the MedTech industry globally and in Brazil, enhancing healthcare delivery and improving patient outcomes through process optimization and data-driven decisions. Responsible AI use, as highlighted by the World Economic Forum, promises life-saving innovations and increased efficiency but requires careful regulatory navigation and transparency. Pure Global's regulatory expertise ensures the swift and successful market introduction of medical technologies in Brazil, fostering innovative healthcare solutions.

Blog Article
Pure Global: Regulatory Decisions for Global Success

Discover how to navigate commercial and regulatory challenges for global success in the medical device industry. Learn strategies for market access, regulatory compliance, and post-market vigilance

Blog Article
New Standards in Medical Device Cybersecurity

Raising cybersecurity standards for medical devices necessitates manufacturers' compliance with new global regulations.

Blog Article
A Strategic Alliance with Pure Global in Brazil

Brazil stands as Latin America's largest medical device market, regulated by ANVISA with recent updates to accommodate new technologies and international harmonization.

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Let's Talk,
Anywhere You Are.

Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.

Our closest representative will get back to you within 24 hours.
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