Sectors
Where our technologies are used
As a medical device start-up in particular, you’ll benefit from our ability to help you bring your products to market and establish them more quickly and cost-effectively. However, we’re also the right partner for many other sectors and requirements.
Medical technology
30+
Key Facts about Medical Technology
40%
F&E-Investitionsquote
100%
Zuverlässigkeit
Start a project
Would you like to ensure the successful implementation of your medical technology project? We support you in implementing regulatory requirements in a structured and efficient manner.
Specialist services in medical technology
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Development
Conceptualisation and development of products eligible for approval – from the initial idea through to prototypes and technical documentation, always taking regulatory requirements into account. -
Produktregistrierung (swissdamed / EUDAMED)
Transition to a stable, scalable implementation – including production set-up, supplier management and ensuring compliant processes throughout the entire value chain. -
Market launch
Support right through to market launch – from regulatory approval and positioning through to access to relevant distribution channels and initial market partners. -
QMS-Aufbau gemäss ISO 13485
Wir implementieren für Sie ein auditsicheres, ISO-13485-konformes Qualitätsmanagementsystem auf, das jeder Prüfung standhält. -
Digitalisierte, validierte Dokumentationsprozesse
Mit unserer validierten und auditierbaren IT-Plattform digitalisieren Sie Ihre gesamte Medizinprodukte-Dokumentation und ersetzen manuelle, fehleranfällige Prozesse. -
Vigilance Reporting / Post-Market Surveillance
Wir übernehmen Ihr Vigilance Reporting und die Post-Market Surveillance nach Schweizer und EU-Vorgaben, damit kein meldepflichtiger Vorfall durchs Raster fällt. -
Fachkräftevermittlung Regulatory Affairs
Aus unserem Team und unserem Netzwerk vermitteln wir Ihnen erfahrene Regulatory-Affairs- und QM-Spezialisten genau dann, wenn Sie sie brauchen.
-
Development
Conceptualisation and development of products eligible for approval – from the initial idea through to prototypes and technical documentation, always taking regulatory requirements into account.
-
Produktregistrierung (swissdamed / EUDAMED)
Transition to a stable, scalable implementation – including production set-up, supplier management and ensuring compliant processes throughout the entire value chain.
-
Market launch
Support right through to market launch – from regulatory approval and positioning through to access to relevant distribution channels and initial market partners.
-
QMS-Aufbau gemäss ISO 13485
Wir implementieren für Sie ein auditsicheres, ISO-13485-konformes Qualitätsmanagementsystem auf, das jeder Prüfung standhält.
-
Digitalisierte, validierte Dokumentationsprozesse
Mit unserer validierten und auditierbaren IT-Plattform digitalisieren Sie Ihre gesamte Medizinprodukte-Dokumentation und ersetzen manuelle, fehleranfällige Prozesse.
-
Vigilance Reporting / Post-Market Surveillance
Wir übernehmen Ihr Vigilance Reporting und die Post-Market Surveillance nach Schweizer und EU-Vorgaben, damit kein meldepflichtiger Vorfall durchs Raster fällt.
-
Fachkräftevermittlung Regulatory Affairs
Aus unserem Team und unserem Netzwerk vermitteln wir Ihnen erfahrene Regulatory-Affairs- und QM-Spezialisten genau dann, wenn Sie sie brauchen.
Other sectors
Public administration & government bodies |
The sensitive handling of data and clear legal requirements characterise day-to-day work. We enable controlled data management, traceable processes and clear access structures. |
Research & Development |
Data is generated across different locations, and collaboration often takes place across multiple teams. We ensure a consistent data foundation and structure the handling of information throughout its entire lifecycle |
Organisations handling sensitive data |
The sensitive handling of data and clear legal requirements characterise day-to-day work. We enable controlled data management, traceable processes and clear access structures. |
Start a project
Would you like to ensure the successful implementation of your medical technology project? We support you in implementing regulatory requirements in a structured and efficient manner.