Zero-Defect Philosophy
for Your Patients
Highest standards in medical technology – certified, tested, documented.
ISO 13485 Quality Management
DIN EN ISO 13485:2021 – certified by PÜG Prüf- und Überwachungsgesellschaft mbH, valid from 04 Jan 2026 to 03 Jan 2029.
From Goods Receipt to Dispatch
- Visual inspection of all raw materials
- Certificate verification (material, batch)
- Digital recording in QM system
- Release or rejection
- 5-axis CNC machining
- SPC (Statistical Process Control)
- Regular interim inspections
- Process documentation
- 3D coordinate measuring technology (Renishaw/Keyence)
- Optical inspection with digital microscopy
- Function and leak testing
- Digital test protocol
- Final visual inspection
- Unique identification (batch/serial number)
- Creation of declaration of conformity
- Packaging and documented dispatch
- Visual inspection of all raw materials
- Certificate verification (material, batch)
- Digital recording in QM system
- Release or rejection
- 5-axis CNC machining
- SPC (Statistical Process Control)
- Regular interim inspections
- Process documentation
- 3D coordinate measuring technology (Renishaw/Keyence)
- Optical inspection with digital microscopy
- Function and leak testing
- Digital test protocol
- Final visual inspection
- Unique identification (batch/serial number)
- Creation of declaration of conformity
- Packaging and documented dispatch
Complete Traceability
Each product receives a unique identification – digitally documented from material to delivery.
Micrometer-Precise Measurement
Every component undergoes 100% quality control with state-of-the-art measuring technology. Our GARANT MM1 device (2D measuring technology) detects deviations in the µm range and guarantees the highest precision.
State-of-the-Art Testing and Measurement Technology
State-of-the-art technology for 100% quality control – every product is tested and digitally documented.
2D Coordinate Measuring Technology
Precision in the µm range with GARANT MM1 (2D measuring technology)
Optical Testing
High-resolution digital microscopy for perfect surfaces
Functional Tests and Cutting Test
100% testing of every product before release
✓ Digital Test Protocols
All measured values are digitally recorded and archived with a unique batch/serial number.
Every Detail Counts
From incoming goods inspection through production to final inspection: Every step is documented, tested and released. Our complete quality control ensures the highest standards.
Complete Traceability
Each product receives a unique identification – digitally documented from material to delivery.
Quality through qualified employees
Quality is created by people who know what they are doing. Continuous training and qualifications are the foundation of our work.
Tested quality – ready for delivery
Certified Inspectors & Training
Qualified employees with regular training on QA standards and testing methods
Quality as Team Responsibility
From manufacturing to delivery – every employee bears responsibility for the highest quality
Trust through Quality
Our certifications and standards guarantee the highest quality Made in Germany.
Quality Promise
Since 1991 in medical technology. Every product undergoes 100% quality control and is made fully traceable with digital documentation. Your safety is our responsibility.
Certificates & Documents
Current quality certificates and documents for download.
ISO 13485:2021 Certificate
Valid until 03 Jan 2029 · PDF, 1.2 MB
Quality Policy
Our quality principles · PDF, 320 KB
Declarations of Conformity
Product-specific documents · ZIP, 2.4 MB
FAQ – Quality
What does ISO 13485 mean?
ISO 13485 is the international standard for quality management systems in medical technology. It ensures that all processes are documented, monitored and continuously improved.
How often do audits take place?
External audits by the certification body take place annually. In addition, we regularly conduct internal audits.
Are all products traceable?
Yes, 100%. Each product receives a unique serial or batch number for complete traceability.
Do I receive test protocols?
Upon request, we are happy to provide product-specific test protocols and declarations of conformity.
What measuring technology do you use?
We use state-of-the-art measuring technology with GARANT MM1 (2D measuring technology), digital microscopy and leak tests. All devices are regularly calibrated.
Experience our quality
Do you have questions about our quality processes? We look forward to hearing from you.
