We Passed Our Exams!
We Are Now Certified!

Certification based on a quality management standard is an important step in our company’s development. To keep our services at the highest level, we had our services analyzed by experts. This proves to our customers how serious we are about our quality management systems! Our product quality is ensured through regular inspections, to offer our customers confidence and confirm our high standards. The continuous improvement process guarantees that the demands and expectations of our partners and employees will be satisfied; long-term business relationships are only possible with satisfied customers and products of impeccable quality.

After thorough study, external quality examiners have granted us the following certification:

EC Certificate
Full Quality Assurance System
Directive 93/42/EEC on Medical Devices (MDD),
Annex II excluding (4)
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EN ISO 13485:2016
Medical devices – Quality management systems –
Requirements for regulatory purposes (ISO 13485:2016)
DIN EN ISO 13485:2016

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