Unitron Group BV

medical devices

About

Unitron Group B.V. is a Dutch company based in IJzendijke, specializing in the development and manufacturing of high-end life science and medical devices. With over 30 years of experience, the company focuses on innovation, quality, and flexibility, delivering reliable products to clients worldwide. Founded in 1988, Unitron employs between 50 and 99 people and exports up to 75% of its products. The company offers comprehensive services, including full-cycle manufacturing for complex medical equipment, hardware and software development, regulatory support for CE and FDA certification, project management, and customized logistics. Unitron is committed to maintaining high standards, complying with ISO 13485 and other regulatory requirements. Their products are designed in collaboration with major healthcare players, ensuring they meet the highest standards of reliability and innovation.

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Keywords

medical iv biomedical device medical manufacturing design transfer ce an fda certification support mdr & ivdr support iso13485 ministerial ordinance 169 & fda sophisticated partnerships medical equipment and supplies manufacturing ce certificering consulting medical device testing clinical support medical device regulation thermische systemen customized service services productie medical devices life sciences diagnostische apparatuur elektronica mechanical engineering kwaliteit medische apparatuur product development medical devices & equipment manufacturing medical device development medical device assembly

Location

7 Schansestraat, IJzendijke, Zeeland, Netherlands, 4515 RN

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