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Blog Article
The EU Parliament votes on a resolution to revise specific parts of the 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
Transla.ai: Simplifying Multi-Language Documentation for Global MedTech Companies

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
Effectively Managing Supplier Audits Across Global Supply Chains

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.

Blog Article
Changing Global Markets - Brazil: Navigating New Regulatory Landscapes

Brazil aligns medical device regulations with global standards, including Europe and the US. Recent updates and international compatibility attract manufacturers.

Blog Article
The Impact of AI on Brazil's MedTech Sector

AI is revolutionizing MedTech in Brazil, enhancing healthcare through process optimization and data-driven decisions. Pure Global ensures swift, compliant market introduction of innovative 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 Med Dev Cybersecurity

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

Blog Article
Brazilian Markets Navigation: Pure Global Alliance

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

Blog Article
US Regulatory insights: Global Collaboration

Combining expert regulatory guidance with cutting-edge clinical laboratory support to streamline the FDA approval process.

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