EN ISO 13485
Our quality management system is certified to EN ISO 13485, the standard for medical devices. It governs every step from development through purchasing to delivery and is regularly audited externally.
Standards
Quality
Every device that leaves our factory is individually tested. Developed and manufactured in Berlin.
Quality is measurable
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100 % individual testing
No sampling: every device passes a complete electrical safety and function test before it ships.
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Made in Berlin
Development, manufacturing and final testing at a single site. Short paths between lab and production make quality a daily routine.
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End-to-end traceability
Serial numbers and test reports link every delivered device to its production batch, traceable across its entire service life.
Tested to international standards
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IEC 60601-1
Safety for the patient environment: our products meet the international standard for medical electrical equipment, from insulation strength to electromagnetic compatibility.
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UL recognized
Our network isolators are recognized by Underwriters Laboratories as a Recognized Component, for building into devices for the USA and Canada.
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ISO 9001
Certified quality management beyond medical technology, too: standardized processes ensure consistently high product quality in every batch.
[Bild und Kennzahlen folgen: Endprüfung/Prüfplatz in der Berliner Fertigung, z. B. Prüfschritte pro Gerät]
Certificates in detail
You will find all certificates and declarations of conformity collected on our certifications page.
View certifications