Phyllis Meng, CEO of Pure Global, shares insights into their innovative approach to revolutionizing the medical device industry.
Originating from the urgent need for masks during the COVID pandemic, Pure Global now focuses on streamlining regulatory processes. The startup provides comprehensive regulatory support, leveraging AI and global partnerships to aid MedTech companies. Meng discusses challenges faced, the diverse clientele served, and emphasizes the company's vision for the future. Aspiring entrepreneurs are advised to prioritize learning, resilience, problem-solving, and strategic decision-making.
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As 2024 comes to a close, Pure Global proudly reflects on a transformative year marked by substantial growth, cutting-edge innovation, and impactful collaborations.
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.
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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.