Our Story

Welcome to NUTOPI, where a decade of experience in production, quality control, and development of In Vitro Diagnostic (IVD) products defines our expertise. NUTOPI Sp. z o. o. provides outsourcing services for SMEs, with a team of scientists who possess broad knowledge in techniques such as ELISA, LFI, and Clinical Chemistry. Our services also include the preparation of regulatory documentation and field testing, all aimed at providing comprehensive support to our clients.

Since our inception on March 10, 2014, NUTOPI has specialized in developing, manufacturing, and monitoring in-vitro medical devices. Based in Poznań, Poland, we support startups and SMEs through every stage from concept to market, ensuring the highest quality in product development and manufacturing with our ISO 13485-certified processes.

Our Expertise:
Development and Manufacturing: We have 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.

Vision

Our vision is to empower all people to be able to test, monitor, and better understand their health. We believe that everyone can be more involved in their own health if the right tools are available.

Mission

Our mission is to provide our customers with reliable and affordable services that help them achieve their goals. We aim to cooperate with SMEs with a similar vision to create products that can change the world.

Goals

Our goal is to create a platform where SMEs can outsource their R&D and manufacturing. We strive to offer engaging services that help our customers produce the best products possible. With extensive knowledge of the market in Poland, we aim to provide affordable products so the end customer can offer low-cost tests for clinics as well as for home testing.

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.

We invite you to cooperate! "You have the innovative product; we have the expertise and platform to launch it successfully into the market."

Please send your inquiries to info@nutopi.com.

The Rises Team

Tomasz Pielak

Founder and CEO

Driven by a profound passion for the medical diagnostics industry, our founder and CEO has dedicated his career to advancing the field. For over a 10 years leads our journey in the development of IVD products, guiding the team with passion and commitment to discovering innovative solutions in medical diagnostics.

Agata Zandecka

Head of Quality

Since the establishment of our company, she has been an integral part of our team, working diligently through all stages of IVD product development. Currently, she leads the Quality Department with unmatched expertise and dedication. As a certified internal auditor of the ISO 13485 system, which she both established and continues to enhance, her contributions ensure our products meet the highest standards of excellence and compliance.

Marcin Czyż, PhD

QC Specialist, Scientist-Projects Leader – Expert in Turbidimetric Assay

Company’s leading scientist possesses extensive knowledge and experience in the validation of turbidimetric methods, development and production of IVD products based on these techniques. With a deep understanding of both European and American regulatory requirements for IVD products validation, he brings invaluable expertise to our team, ensuring IVD products comply with international standards.

Marcin Pyrski, PhD

Production Manager, QC Specialist, Scientist-Projects Leader - Expert in ELISA and LFI assay

Reliable Production Manager, scientist, an expert in the research and development of products utilizing ELISA and LFI methods. He oversees our production and quality control processes, ensuring each step adheres to our stringent standards. As a project leader at our company, he excels in managing customer relations, consistently upholding the highest level of service.