OEM development and ISO 13485-compliant series production of devices for medical technology, diagnostics and laboratory technology.
DITABIS – Digital Biomedical Imaging Systems AG
75179 Pforzheim (Freiburger Str. 3, Wilferdinger Höhe)New on Amplifa
About DITABIS
DITABIS – Digital Biomedical Imaging Systems AG is a service company for the development and manufacture of devices with a focus on medical technology, diagnostics, laboratory technology and life sciences. Founded in 1996 as a spin-off of today's Stratec SE and headquartered in Pforzheim, the company develops mechanics, electronics, firmware, software and user interfaces under one roof as an OEM partner and takes products from feasibility assessment through prototyping (A, B and C samples) to ISO 13485-compliant series production. Manufacturing covers the assembly of complex components such as electronic assemblies (ESD-compliant), optics and mechanics, sensor technology and micromechanics, displays, control modules as well as cable sets and connectors. DITABIS manufactures small and medium series (up to approx. 5,000 devices per year and device), also undertakes contract manufacturing of externally developed devices and supports products with life-cycle management, certification support (CE, FDA, MDR, IVDR) and worldwide logistics. In addition to medical and laboratory technology, the company serves other industrial sectors such as robotics, automation and defense.
- Site
- Pforzheim
- Processes
- OEM development and manufacturing (mechanics, electronics, firmware, software, UI), Prototyping / prototype construction (A/B/C samples, 3D printing of components), Series assembly of devices and device components (assembly lines), ESD-compliant assembly of electronic assemblies incl. functional testing, Assembly and precise alignment of optics & mechanics, Assembly of sensor technology & micromechanics (sensitive handling, full traceability), Integration of displays & control modules, Manufacturing of cable sets & connectors
- Materials
- OEM development and manufacturing, ESD-compliant electronics assembly, Optics and micromechanics assembly, 3D printing of components, Cable set manufacturing, Contract manufacturing of externally developed devices
- Certificates
- ISO 13485
- Founded
- 1996
- Industries
- Medical technology, Diagnostics, Laboratory technology, Life sciences, Robotics, Automation
- 01
Feasibility assessment and cost estimation
- 02
Concept development (mechanics, electronics, software, usability, regulatory)
- 03
Development with prototyping (A/B/C samples, 3D printing)
- 04
Pre-series, verification/validation and certification support (CE, FDA,
- 05
Series transfer and series assembly on assembly lines (ESD-compliant,
- 06
Quality assurance, functional testing, kitting and packaging
- 07
Life-cycle management: service, maintenance, spare parts supply, reverse
Processes and Competencies
OEM development and manufacturing
Interdisciplinary implementation of mechanics, electronics, firmware, software and UI through to series production.
ESD-compliant electronics assembly
Assembly of electronic assemblies including functional testing in an ESD-compliant environment.
Optics and micromechanics assembly
Precise alignment of optics, sensor technology and micromechanics with full traceability.
3D printing of components
Housings and mechanics of individual components are produced by 3D printing in the prototyping area.
Cable set manufacturing
Manufacturing of cable sets and connectors with structured cable routing and tested connections.
Contract manufacturing of externally developed devices
Series production of third-party developments including test concepts, quality management, logistics and worldwide shipping.
Pforzheim Site
Pforzheim
DEHeadquarters: development, production, quality assurance, logistics
- Part weight / size
- small and medium-sized devices ("fits through the door")
- Lot size
- 1 – 100, 100 – 1,000, >1,000 per year
- Materials
- Electronics, optics/mechanics, sensor technology, micromechanics, displays, cable sets
- Assembly lines
- ESD-compliant assembly areas
- 3D printing (prototyping)
- ERP-supported quality assurance
Reference Projects and Components
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| OEM development and manufacturing (mechanics, electronics, firmware, software, UI)Engineering | – | – | – | – | – |
| Prototyping / prototype construction (A/B/C samples, 3D printing of components)Engineering | – | – | – | – | – |
| Series assembly of devices and device components (assembly lines)Assembly | – | fits through the door | – | 1 unit/year – approx. 5,000 units/year and device | – |
| ESD-compliant assembly of electronic assemblies incl. functional testingAssembly | – | – | – | – | – |
| Assembly and precise alignment of optics & mechanicsAssembly | – | – | – | – | – |
| Assembly of sensor technology & micromechanics (sensitive handling, full traceability)Assembly | – | – | – | – | – |
| Integration of displays & control modulesAssembly | – | – | – | – | – |
| Manufacturing of cable sets & connectorsJoining | – | – | – | – | – |
| Contract manufacturing of externally developed devices incl. test concepts, QM, logisticsAssembly | – | – | – | – | – |
| Semi-automated series production for large volumes (>1,000)Assembly | – | – | – | 1,000 | – |
| Certification support (ISO 13485, CE, FDA, MDR, IVDR)Testing | – | – | – | – | – |
| Life-cycle management: repairs, maintenance, spare parts supply, reverse engineering,Assembly | – | – | – | – | – |
Additional services
Reference customers
Quality and Certification
Production is certified to ISO 13485; quality assurance is ERP-supported with gapless documentation and full traceability. Functional tests, standardized test concepts and audit-proof technical documentation ensure approval under CE, FDA, MDR and IVDR.
| Evidence | Pforzheim |
|---|---|
| ISO 13485 |
History
- 1996
Foundation of DITABIS – Digital Biomedical Imaging Systems AG by Hermann Leistner and Dr. Christof Steiner as a spin-off of today's Stratec SE.
- 2010er
From the mid-2010s, focus on development and production as a service provider with an emphasis on medical and laboratory technology, later expanding into other industrial sectors.