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.

Read full article here.

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Latest News

Browse our news hub featuring company announcements, regulatory updates, and industry insights to keep you informed and ahead of the curve.

Regulatory Update
October 1, 2024

End of September 2024 brought updates from major markets: EU IVDR transition guidance for Class D IVDs, biocompatibility guidance from the US FDA, IVD family grouping regulations from Brazil, and more.

The Pure Global Resource Center consolidates data from over 30 global markets with local expertise, simplifying global standards to identify the most effective market entry routes.

Regulatory Update
September 24, 2024

Medical device regulatory news from the Americas includes enhanced safety and performance standards in Brazil; new device classifications from the US FDA; and a policy for classifying combination products in Canada.

Regulatory Update
September 17, 2024

This week, we cover more ANVISA updates from Brazil, including new labeling requirements for certain devices and a clear path for registration transfers, along with new appraisal requirements for high-risk devices in Vietnam.

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