Debiotech Sa

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With 35 years of experience in the medical device sector, we are passionate about enhancing patient lives through cutting-edge solutions. Our mission is to be your strategic partner in medical device/ SaMD development, guiding you through every phase of your project—from conceptualization and rapid prototyping to successful market launch. Our commitment to excellence is reflected in our deep understanding of regulatory requirements, ensuring that all projects meet the highest quality standards. Together, we can achieve significant progress in healthcare. Certifications: ISO 13485 certified, QMS following FDA 21 CFR Part 820 and MDR ISO/IEC62304, 60601-1, 62366,14971, Services: Product Lifecycle Management Mechanical, Eletrical, and Software Engineering Integration of complexity through Systems Engineering Testing and Quality Engineering Concept Design/Concept Feasibility Design Control, Design Change, Design for Cost, Design for Manufacturing Risk Management Cybersecurity Management Cost/Process Optimization
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The Versi™PD Cycler System conceived and developed by Debiotech and licensed to Fresenius Medical Care receives FDA clearance - PR Newswire

The Versi™PD Cycler System conceived and developed by Debiotech and licensed to Fresenius Medical Care receives FDA clearance PR Newswire

Debiotech Showcases New Insulin “JewelPUMP” at ADA - Making Sense of Diabetes

Debiotech Showcases New Insulin “JewelPUMP” at ADA Making Sense of Diabetes

Major Step Towards Portable Artificial Kidney - Med Device Online

Major Step Towards Portable Artificial Kidney Med Device Online

Neokidney, Debiotech partner to create new company and new home dialysis system - BioWorld MedTech

Neokidney, Debiotech partner to create new company and new home dialysis system BioWorld MedTech

MEMS based insulin pump - New Electronics

MEMS based insulin pump New Electronics

Entirely redesigned insulin JewelPUMP2 - Today's Medical Developments

Entirely redesigned insulin JewelPUMP2 Today's Medical Developments

Neokidney and Debiotech Join Forces in NextKidney SA and Appoint Jérôme Augustin CEO of the New Company - PR Newswire

Neokidney and Debiotech Join Forces in NextKidney SA and Appoint Jérôme Augustin CEO of the New Company PR Newswire

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