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.

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.

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.

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

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.

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

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

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

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