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The EU Parliament votes on a resolution to revise specific parts of the MDR and IVDR
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.

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Transla.ai: Simplifying Multi-Language Documentation for Global MedTech Companies
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.

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Changing Global Markets - Brazil: Navigating New Regulatory Landscapes
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.

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The Impact of AI on Brazil's MedTech Sector
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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.

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Pure Global: Regulatory Decisions for Global Success
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

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New Standards in Med Dev Cybersecurity
Blog Article

New Standards in Med Dev Cybersecurity

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

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Brazilian Markets Navigation: Pure Global Alliance
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.

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US Regulatory insights: Global Collaboration
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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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Partnering with Pure Global Singapore
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Partnering with Pure Global Singapore

With a population of 5+ million, Singapore has the highest GDP per capita in Asia, according to Trading Economics.

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