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 MDR/IVDR, 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),In-vitro-diagnostic regualtion, MDSAP, and the ISO 13485:2016.
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