2D coordinate measurement
Reproducible dimensional inspection with GARANT MM1 in the µm range.
ISO 13485 certified since 2022
Quality that
builds trust
Certified processes, precise measurement technology and complete documentation for surgical instruments and medical components.
Certification
ISO 13485 – independently verified
Our quality management system meets the requirements of DIN EN ISO 13485:2021. The current certification by PÜG Prüf- und Überwachungsgesellschaft mbH is valid from 04 Jan 2026 to 03 Jan 2029.
DIN EN ISO 13485:2021
PÜG Prüf- und Überwachungsgesellschaft mbH
04.01.2026 – 03.01.2029
Period of validity
Quality process
Four controlled steps
Quality does not begin with final inspection. It accompanies every component from incoming material to documented delivery.
- 01
Goods Receipt
Materials and records are checked before manufacturing begins.
Inspection steps- Visual inspection of raw materials
- Material and batch records
- Digital recording and release
- 02
Production
Monitored CNC processes ensure consistent results.
Inspection steps- 5-axis CNC machining
- SPC monitoring
- Documented interim inspections
- 03
Quality Inspection
Every component is measured, inspected and documented.
Inspection steps- 2D coordinate measuring technology
- Optical surface inspection
- Functional and cutting tests
- 04
Release & Dispatch
Final release completes full traceability.
Inspection steps- Final visual and functional inspection
- Batch or serial identification
- Documented packaging and delivery
Complete traceability
Material, inspection and release are uniquely assigned and digitally documented.
Precision measurement
Measurement in the µm range
With GARANT MM1 2D measurement technology, we record relevant dimensions precisely and reproducibly. Results flow directly into documented quality release.
µmMeasurement precision
100 %Inspected components
Testing methods
Systematic inspection
The appropriate testing method is selected according to the geometry, surface and function of each component.
Optical inspection
High-resolution inspection of contours, edges and surfaces.
Functional and cutting tests
Every product is tested under realistic conditions before release.
Final inspection
Every detail counts
From visual inspection to final functional testing, every relevant step is documented, inspected and released.
Digital inspection records
Measured values are assigned to a batch or serial number and archived for full traceability.
Team & expertise
Quality remains a team effort
Experience, regular training and clear responsibilities form the foundation of our quality assurance.
Qualified inspection
Trained employees work according to defined QA standards and testing methods.
Shared responsibility
From manufacturing to delivery, every process step contributes to product quality.
Our quality promise
Since 1991, we have combined medical technology experience with controlled manufacturing. Every component is inspected and documented for traceability.
Evidence & answers
Documents and frequently asked questions
The current certificate is available for direct download. Further product-related records are provided according to your enquiry.
What does ISO 13485 mean?
ISO 13485 is the international standard for quality management systems in medical technology. It requires documented, monitored and continuously improved processes.
How often do audits take place?
External audits by the certification body take place annually. We also carry out regular internal audits.
Are products traceable?
Yes. Relevant material, inspection and release data are assigned via a unique batch or serial identification.
Can I receive inspection records?
We provide product-specific inspection records and conformity documents according to the respective enquiry.
Let’s discuss your quality requirements
Do you need inspection records, evidence or technical coordination? Our team will support you personally.
