Jens Fröhlich
Principal Consultant Operations – Portfolio Management MEDTEC
The TÜV X-ray Report 2026 It paints a clear picture: Every eighth X-ray machine in Germany has defects – some of them with direct implications for patient safety and diagnostic quality.
What is often overlooked is that these deficiencies rarely arise solely from technical defects. Far more frequently, the causes lie in inadequately structured processes surrounding maintenance, service, and quality management. This is precisely where medtec comes in.365 from KUMAVISION.
The real challenge lies in the operation – not in the device.
The deficiencies mentioned in the report – such as those relating to radiation protection, image quality or documentation – arise predominantly during the ongoing operation of the devices.
This means:
Whether an X-ray machine is operated safely and in compliance in the long term depends significantly on how well maintenance, service and quality processes are integrated.
In practice, however, this very consistency is often lacking:
- Maintenance appointments are not consistently followed up.
- Service calls are only rudimentarily documented.
- Complaints remain isolated individual cases.
- The causes are not systematically analyzed.
Addresses precisely these gaps medtec365 through an integrated platform for the entire product lifecycle.
Maintenance and service: From reactive to predictable and transparent
A key lever for reducing defects is the consistent management of maintenance and service.
With medtec365 can be:
- Define maintenance plans centrally and monitor them automatically.
- Fully document all service calls
- Completely track devices, components and histories
The result is a complete overview of the status of the installed device base.
Instead of reacting to TÜV findings, maintenance becomes predictable and controllable.
Typical weaknesses – such as forgotten calibrations or unclear service histories – are thus systematically avoided.
Complaint management: From individual incident to database
Complaints are handled at medtec365 not just processes, but part of an integrated data model.
All relevant information is linked together:
- Complaints
- affected device or series
- associated service call
- Error classification
This creates, for the first time, genuine transparency regarding recurring problems.
Instead of dealing with individual cases, companies can recognize:
- which errors occur frequently
- which device generations are affected
- where systematic weaknesses lie
This is the basis for a functioning quality management – and exactly what the TÜV report says is often missing.
CAPA: The crucial step towards sustainable improvement
The TÜV report indirectly highlights a key problem: defects are rectified, but not sustainably prevented.
The regulatory path is clearly defined:
CAPA (Corrective and Preventive Action) calls for the systematic elimination of causes and the avoidance of recurring errors.
With medtec365 This process will be operationally anchored:
- Service cases and complaints can be directly converted into CAPA measures.
- Root cause analyses are documented in a structured manner
- Measures are tracked, completed, and documented.
- The effectiveness will be reviewed.
This creates a genuine quality control loop – instead of a purely repair process.
The decisive added value: A continuous quality cycle
The strength of medtec365 The key lies not in individual functions, but in integration:
- Maintenance provides structured data
- Service makes problems visible
- Complaints compile feedback from the field.
- CAPA provides sustainable solutions
Everything is based on a common database in the ERP system, which was specifically developed for medical technology manufacturers and distributors.
This is how isolated processes become one consistent closed-loop approach, in which every insight is translated into concrete improvements.
Conclusion: Fewer defects through better processes – not just better equipment
The TÜV X-ray Report 2026 makes it clear:
The quality of X-ray equipment is determined during operation.
With medtec365 Companies can start right there:
- Automate and make maintenance traceable
- Manage service processes transparently
- Systematically evaluate complaints
- Effectively implement CAPA
The result is less reaction – and more prevention.
Or to put it another way: TÜV finds the defects – medtec365 This ensures that they do not occur in the first place or do not recur.
