QUNIQUE (Quality Unique) is a skilled service provider in Switzerland which was founded in 2017 by Angelina Hakim towards serving the various stakeholders including but not limited to the medical device and in-vitro diagnostic industry with tailored and qualitative services.

QUNIQUE ensures qualitative output of its services by involving highly competent and experienced resources in the various professional fields. 


QUNIQUE focuses its activities on regulatory, quality, training and personal development services:

Quality Management Service

  • ISO 13485
  • ISO 9001
  • Medical Device Single Audit Program (MDSAP)

US Food and Drug Administration (FDA) 21 CFR part 820

Medical Device Regulation 2017/745

·      Quality Management System

·      Technical Documentation

·      Clinical Evaluation

·      Post-Market Surveillance

In-Vitro Diagnostic Regulation 2017/746

·      Quality Management System

·      Technical Documentation

·      Performance Evaluation

·      Post-Market Surveillance