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Pure Global is a trusted global leader and growth partner in the healthcare technology industry. Find regulatory insights from our expert team, AI-Powered regulatory news update tool, and meet us at our next event.

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NEWS

Regulatory News

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

An extensive round-up of medical device regulatory news from November 2024 includes new and updated guidance documents, Q&As, and directives from Europe and the US, including the new EU Product Liability Directive for AI and Smart Products.

Pure Global is proud to announce its inclusion in the China Business Service Providers (BSP) directory on the International Trade Administration website.

Regulatory Update
November 20, 2024

This week in medical device regulatory news, Thailand has introduced new refer and transfer guidelines, Europe released an updated Q&A on IVDR and MDR vigilance terms, and Romania has new rules for Economic Operators.

Regulatory Update
November 13, 2024

This week, we bring you medical device regulatory update coverage from around the world, including new registration Q&A resources in Taiwan and Japan, UK relaunches ILAP pathway, Mexico will apply a new acquisition model, and more.

Blog

Recent Blog Posts

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

Risk increases compliance chalenges under IVDR
Blog Article
What are the challenges under IVDR?

IVD manufacturers cite the new classification system, detailed definitions for intended purposes, and the need for verification of clinical evidence as key challenges under the IVDR.

Blog Article
EU Parliament Revises MDR and IVDR

On October 23, the European Parliament adopted a resolution revising specific elements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR). This resolution intends to address ongoing challenges in implementing the regulations by 2025 and to improve patient access to important medical products.

Blog Article
Language Challenges in MedTech Going Global and Our Solution

Multilingual documentation presents ongoing compliance and logistical hurdles for MedTech manufacturers. Transla.Ai is an industry-specific translation tool that can accelerate and streamline the translation process.

Medical device supply chain
Blog Article
Managing your medical device supply chain

The connection between supplier controls and business risks is becoming increasingly evident. In this article, we discuss perspectives on how to maintain a compliant medical device supply chain.

Events

Events

Come meet our team at Pure Global and discover how we can help with your regulatory questions and help you gain market access for your device.

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