QUNIQUE steht für Quality & Uniqueness. Wir streben nach höchster Qualität & Einzigartigkeit in der Beratung der Medizintechnik Branche.

QUNIQUE GmbH ist ein international agierendes Beratungsunternehmen mit Hauptsitz in der Schweiz.

Wir legen dabei den Fokus auf die Beratung in den Bereichen Qualitätsmanagement (ISO 13485, MDSAP, Audits), Regulatory Affairs (Medical Device Regulation (MDR), Technische Dokumentation), Trainings und Compliance Projektmanagement.

 

QUNIQUE provides medical device companies with customised solutions for quality management systems (QMS), supporting the implementation of new processes and training personnel appropriately.

QUNIQUE focuses on compliance and efficiency. Its services cover the whole range, from creating a template or a standard operating procedure (SOP) to implementing a full QMS in compliance with ISO 13485:2016, Medical Device Single Audit Program (MDSAP), US Food and Drug Administration (FDA) 21 CFR part 820, or ISO 9001:2015.

QUNIQUE understands the regulatory requirements for medical device manufacturers, including the EU medical device regulation (MDR), MDSAP, and the ISO 13485:2016.

 

 

 

 

 

 

 

 

 

 

 

 

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