NUTOPI Sp. z o.o.

Welcome to NUTOPI Sp. z o.o., based in Poznań, Poland. "You have the innovative product; we have the expertise and platform to launch it successfully into the market." Since our inception on March 10, 2014, NUTOPI has specialized in developing, manufacturing, and monitoring in-vitro medical devices. Our mission is to advance in-vitro diagnostics, supporting startups and SMEs through every stage from concept to market. Our ISO 13485-certified processes ensure the highest quality in product development and manufacturing. Our Expertise: - Development and Manufacturing: We've developed three main products and thirteen sub-products, managing everything from validation to market readiness. - Regulatory Support: We provide comprehensive documentation and compliance services for standards like ISO, IVD, IVDR, EUA, and FDA 510K. Case Study: Our partnership with ViroGates A/S led to the development and market launch of four innovative products. We managed the development processes and performed extensive validations using LFI, Turbidimetry and ELISA techniques, ensuring rigorous clinical and analytical accuracy. This comprehensive approach accelerated their product introductions, showcasing our deep expertise in complex diagnostic technologies. Why Partner with Us? - Expert Team on a Budget: Avoid stretching your budget thin across multiple roles. Our team offers everything from development to regulatory compliance, acting as an extension of your team. - Dedicated Support: We prioritize your needs, ensuring you never feel sidelined by larger manufacturers. With NUTOPI, you're always in the front row, receiving the attention and responsiveness you deserve. Join Us: Be part of a journey that enhances global healthcare through innovative solutions. Connect with us to turn your ideas into market-ready products.

• Employees 5
• Founded 2014