- For medical technology companies
Medizintechnik – Präzision für regulierte Systeme
Als ISO 13485 zertifizierter Spezialist entwickeln und fertigen wir elektromechanische Baugruppen für sicherheitskritische Medizingeräte – normkonform, validiert und serienreif.
Von der Konzeptphase bis zur validierten Serie übernehmen wir Verantwortung für Integration, Dokumentation und regulatorische Sicherheit.
Kennen Sie diese regulatorischen Herausforderungen?
Lange Entwicklungszyklen durch Validierungsanforderungen?
We optimize your development processes and work in parallel on hardware, software and approval documents.
Hoher Dokumentationsaufwand für MDR- und FDA-Konformität?
Our team knows the approval requirements — we develop in compliance with approval from day 1.
Verzögerungen durch nicht normgerechte Schnittstellen?
Our expertise helps you avoid expensive rework and delays in the approval phase.
Why medical technology companies trust us
Regulatorische Systemverantwortung
Entwicklung und Fertigung nach ISO 13485 – mit klarer Dokumentationsstruktur und validierten Prozessen.
- Beatmungsgeräte-Komponenten: Präzise abgestimmte Baugruppen und Feinmechanikteile
- Gas supply components: Specialized valve and flow regulator assemblies for medical gas systems
- Medical infrastructure: Specialized socket strips and special cables for operating theatres and intensive care areas
Validierte Qualität über den Lebenszyklus
Rückverfolgbarkeit, Prüfplanung und Prozessvalidierung sichern reproduzierbare Ergebnisse – vom Prototyp bis zur Serie.
- ISO 13485 certification: Prequalified manufacturing platform for shorter approval times
- Reliable partner for standard-compliant medical technology development
- <10 ppm failure rates: Highest quality and reliability for critical medical devices
Integration für kritische Systeme
Elektromechanische Baugruppen mit definierter Schnittstellenverantwortung für stabile und normkonforme Gesamtsysteme.
- ESD-compliant production: Antistatic production environment for sensitive medical components
- Validated processes: ISO 13485-compliant production processes with complete documentation
- Medical-specific testing: functional and safety tests in accordance with international medical standards
Regulatory success — your innovation reaches the market through proven compliance processes
Complete traceability — Complete documentation for audit and certification processes
Failure rates — Maximum reliability for critical medical devices
Free of charge ISO 13485 -
Secure advice
- Free compliance analysis for your medical technology requirements
- Approval optimization from development to market release
- ISO 13485 manufacturing platform from a single source
What our customers say:
Frequently asked questions
What approvals do medical devices need?
Depending on the risk class, CE marking, FDA approval or further certifications required. Our ISO 13485:2016 certification speeds up the process considerably.
How long does it take to develop a medical device?
Thanks to our parallel development and prequalified platform we shorten the usual development time by 6 months. Furthermore our existing certification eliminates the need for initial auditing for Your project.
Which materials are approved for medical devices?
We process biocompatible plastics (USP Class VI), stainless steels (316L) and other medically approved materials.
Which manufacturing processes do you use for medical products?
Injection molding for housings, precision machining for metal components, as well as additive manufacturing for prototypes and Small series.
How do you ensure standards-compliant documentation?
Our KOMOS app automatically documents all quality-critical process steps conform to standards. Test protocols are created automatically and, if desired, transmitted to you This speeds up the approval process and documentation considerably.