Company Update

StartUp Valley Founder Talk

Phyllis Meng, CEO of Pure Global, shares insights into their innovative approach to revolutionizing the medical device industry.

Published on:
April 2, 2024

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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Recent global regulatory updates include changes for software-based medical devices, prescription lenses, and microbial, recombinant, or animal substances. Effective June 15 and July 1, 2024, with reclassification by July 1, 2026. High-risk devices have limited audits; spectacle lenses are ARTG exempt from June 15.

Regulatory Update
June 4, 2024

In May 2024, major regulatory updates were announced across the UK, EU and Switzerland to enhance medical and in vitro diagnostic devices. The COMBINE project was launched to streamline regulations, and new standards and frameworks were proposed to improve safety, compliance, and timely access to innovative treatments.

In an interview with TechNews180, Pure Global CEO Phyllis Meng discusses how AI and data analytics are revolutionizing market access and regulatory compliance for MedTech companies. Meng highlights Pure Global's platform, which provides seamless access to global registration data and clinical trial information, eliminating manual searches.

Unlock efficient market access with Pure Global & MEDIcept's collaboration. From registration to regulatory expertise, we offer comprehensive solutions worldwide. Drive growth & innovation in MedTech.

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