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Pure Global Partners with MEDIcept to Enhance Medical Device and IVD Market Entry

Pure Global and MEDIcept unite to streamline global market entry for MedTech
May 8, 2024

In a significant move to advance the medical device and in vitro diagnostics (IVD) industries, Pure Global and MEDIcept have announced a strategic collaboration designed to streamline global market access and regulatory pathways. This partnership leverages Pure Global's global market access services and MEDIcept’s expertise in US and EU regulatory, quality, and clinical services, aiming to transform challenges into opportunities across international borders.

By integrating Pure Global’s global representation and advanced AIGC regulatory tools with MEDIcept's robust US and EU market expertise, the collaboration seeks to simplify the complexities of regulatory compliance and market entry. This synergy enhances their service offerings, allowing them to provide comprehensive regulatory affairs, quality assurance, clinical support, and market representation in key regions including the US, Latin America, Europe, the Middle East, and Asia Pacific.

The collaboration is set to bring significant benefits to the industry by combining the strengths of both companies to better navigate regulatory landscapes and facilitate smoother market access. Key objectives of the partnership include expanding service reach, enhancing research capabilities through advanced tools, and designing global clinical studies to support market and post-market activities.

The companies anticipate that their joint efforts will not only drive growth and innovation within the medical device and IVD fields but also deliver greater value and efficiency to their clients worldwide. The initial stages of the alliance will focus on a joint marketing initiative to promote their expanded service portfolio.

Zhu (Phyllis) Meng, CEO of Pure Global, commented on the partnership, stating, "Pure Global's strategic alliance with MEDIcept will help accelerate MedTech innovation and streamline compliance. By combining their hundreds of successful submissions since 1996 with our AI-powered & data driven regulatory solutions, we empower clients worldwide to bring life-changing MedTech to market faster, with reduced costs and higher regulatory success.”

David Rothkopf, President of MEDIcept, added, "With this strategic alliance we are strengthening our worldwide presence and can serve the needs of our customers anywhere. With teams of seasoned consultants both MEDIcept and Pure Global offer deep expertise across a wide range of compliance needs. Together, this relationship will efficiently help international companies with FDA and US quality, regulatory, clinical, and reimbursement concerns and rapidly provide tailored, trusted solutions to meet their unique challenges."

As they move forward, both Pure Global and MEDIcept are enthusiastic about the potential of their partnership to revolutionize market access for medical technologies globally.

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