Ditabis
Contract design, development and manufacturing organization for medical, diagnostic and laboratory devices. Provides integrated device engineering (mechanical, electronic, firmware and software), ISO 13485‑aligned quality and regulatory support for European and selected international markets, small- and mid-volume production in Germany, lifecycle services (repair, spare parts, maintenance) and active participation in applied research consortia to move prototypes toward clinical validation and series manufacturing.
Industries
Nr. of Employees
small (1-50)
Ditabis
Pforzheim, Baden-Wurttemberg, Germany, Europe
Services
End‑to‑end engineering services from concept and feasibility to regulatory‑ready technical documentation.
Small to medium series production, assembly, test and packaging with ESD controls and documented end‑of‑line testing.
Project‑integrated RA and QM support including risk management (ISO 14971), technical documentation, clinical evaluation input and audit preparation for CE/MDR/IVDR and selected international submissions.
Repairs, maintenance, spare‑parts stocking, software/firmware updates, product modernization and reverse engineering to sustain devices in the field.
Rapid prototyping, functional and environmental testing, usability studies and generation of verification/validation evidence for regulatory submissions.
End‑to‑end engineering services from concept and feasibility to regulatory‑ready technical documentation.
Small to medium series production, assembly, test and packaging with ESD controls and documented end‑of‑line testing.
Project‑integrated RA and QM support including risk management (ISO 14971), technical documentation, clinical evaluation input and audit preparation for CE/MDR/IVDR and selected international submissions.
Repairs, maintenance, spare‑parts stocking, software/firmware updates, product modernization and reverse engineering to sustain devices in the field.
Rapid prototyping, functional and environmental testing, usability studies and generation of verification/validation evidence for regulatory submissions.
Expertise Areas
- OEM product development
- Medical device development (MedTech & IVD)
- Regulatory compliance and submissions (MDR/IVDR/CE, FDA 510(k))
- ISO 13485 quality management
Key Technologies
- Embedded systems and firmware
- Cloud integration and remote update systems
- Time‑resolved fluorescence detection
- Single‑photon avalanche diode (SPAD) sensing
News & Updates
Organization certified to DIN EN ISO 13485 for relevant areas since 2015; certificate available for download.
Organization certified to DIN EN ISO 9001 for relevant areas since 2015; certificate available for download.
Partner in a national research consortium developing a compact photonic point‑of‑care system using time‑resolved fluorescence detection for rapid multi‑resistance diagnostics.
Contributed system integration and testing for a wearable ultrasound biofeedback device incorporating mobile deep‑learning processing and real‑time feedback.
Developed a network‑capable mobile demonstrator for automated bladder‑irrigation monitoring and real‑time analysis; project concluded in October 2020.
Organization certified to DIN EN ISO 13485 for relevant areas since 2015; certificate available for download.
Organization certified to DIN EN ISO 9001 for relevant areas since 2015; certificate available for download.
Partner in a national research consortium developing a compact photonic point‑of‑care system using time‑resolved fluorescence detection for rapid multi‑resistance diagnostics.
Contributed system integration and testing for a wearable ultrasound biofeedback device incorporating mobile deep‑learning processing and real‑time feedback.
Developed a network‑capable mobile demonstrator for automated bladder‑irrigation monitoring and real‑time analysis; project concluded in October 2020.