Ditabis
Contract design and manufacturing organization (OEM/CDMO) for medical, diagnostic and laboratory devices. Provides interdisciplinary product development (mechanics, electronics, firmware, software, UI), ISO 13485‑certified series manufacturing in Germany, regulatory support for CE/MDR/IVDR and FDA pathways, and long‑term life‑cycle management. Active in collaborative research consortia and prototype demonstrators for photonic diagnostics, wearable ultrasound systems and other medical imaging applications.
Industries
Nr. of Employees
small (1-50)
Products
Contract manufacturing of medical and laboratory devices
Manufacture and delivery of finished medical and laboratory devices produced to customer specifications, with documented quality control and packaging for international shipment.
Contract manufacturing of medical and laboratory devices
Manufacture and delivery of finished medical and laboratory devices produced to customer specifications, with documented quality control and packaging for international shipment.
Services
End-to-end development of medical and laboratory devices including mechanics, electronics, firmware, software, prototyping and technical documentation.
Small to medium series production including PCB/electronics, optics/mechanics, sensor assembly, cabling, final integration, packaging and international shipping with ERP traceability.
Project-integrated regulatory support including preparation of technical documentation, clinical evaluation, CE/MDR/IVDR activities, FDA 510(k) preparation and audit readiness.
Long-term product support including maintenance, repairs, spare-parts management, firmware/hardware updates, modernization and reverse engineering.
Supplier coordination, framework agreements, rolling forecasts, inventory management and logistics support integrated with ERP systems.
Collaboration in multi-partner research projects to develop photonic POC systems, wearable ultrasound demonstrators and other prototype devices, including system integration, real-time signal processing and clinical demonstrator support.
End-to-end development of medical and laboratory devices including mechanics, electronics, firmware, software, prototyping and technical documentation.
Small to medium series production including PCB/electronics, optics/mechanics, sensor assembly, cabling, final integration, packaging and international shipping with ERP traceability.
Project-integrated regulatory support including preparation of technical documentation, clinical evaluation, CE/MDR/IVDR activities, FDA 510(k) preparation and audit readiness.
Long-term product support including maintenance, repairs, spare-parts management, firmware/hardware updates, modernization and reverse engineering.
Supplier coordination, framework agreements, rolling forecasts, inventory management and logistics support integrated with ERP systems.
Collaboration in multi-partner research projects to develop photonic POC systems, wearable ultrasound demonstrators and other prototype devices, including system integration, real-time signal processing and clinical demonstrator support.
Expertise Areas
- Contract design and manufacturing (OEM/CDMO) for medical and laboratory devices
- Medical device design engineering (mechanical, electronic, firmware, software, UI)
- ISO 13485 quality management and design controls
- Regulatory compliance and submission support (CE/MDR/IVDR and FDA 510(k))
Key Technologies
- Embedded firmware
- Medical device software and UI
- ESD-compliant electronics assembly
- Sensor integration and micromechanics
News & Updates
Summary post reflecting on participation at Medica 2024, partnerships and technologies showcased.
Article discussing how artificial intelligence supports image data analysis in diagnostics and the continued role of human clinical decision making.
Announcement describing a next generation of imaging sensors designed for integration into complex medical systems.
Development of a mobile, network-capable prototype demonstrator for automated bladder irrigation monitoring with real-time analysis; project completed in October 2020.
Summary post reflecting on participation at Medica 2024, partnerships and technologies showcased.
Article discussing how artificial intelligence supports image data analysis in diagnostics and the continued role of human clinical decision making.
Announcement describing a next generation of imaging sensors designed for integration into complex medical systems.
Development of a mobile, network-capable prototype demonstrator for automated bladder irrigation monitoring with real-time analysis; project completed in October 2020.