Welcome at QUNIQUE

Quality and
Regulatory Consultancy

Quality and Regulatory Consultancy

Customer oriented solutions

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

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

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QUNIQUE 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.

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

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Quality Management Service

  • ISO 13485
  • ISO 9001
  • Medical Device Single Audit Program (MDSAP)
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Medical Device Regulation 2017/745

  • Quality Management System
  • Technical Documentation
  • Clinical Evaluation
  • Post-Market Surveillance
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In-Vitro Diagnostic Regulation 2017/746

  • Quality Management System
  • Technical Documentation
  • Performance Evaluation
  • Post-Market Surveillance
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US Food and Drug Administration (FDA) 21 CFR part 820

Service Areas

Quality Management

QUNIQUE`s experienced and qualified lead auditors can train, educate and prepare industrial personnel for audit in the various regulatory fields.

REGULATORY-AFFAIRS

QUNIQUE´s experienced resources help you finding the leanest and most predictable way to get a new medical device or an in-vitro diagnostic device to a specific market.

PROJECT-MANAGEMENT

Regulated markets and specifically those overseen by either a government or other independent organizations face continuously changing legal obligations.

LEADERSHIP

We do understand that taking the next step in your career through starting a new position or stepping up within the same organization might be accompanied with some challenges.

Trainings

QUNIQUE delivers in-house and public training with top international speakers and subject matter experts towards addressing the various customer needs.

Publications

The update of regulations, guidance documents and regional expectations are leading to a lot of confusion at the various stakeholders in the medical device and In-Vitro Diagnostic sectors. QUNIQUE Group Team keep publishing news and interpretation documents helping everyone to understand the latest information and prepare accordingly.

European-Regulations

The European regulations are binding legislative acts which are applicable across the about these requirements.

International-Affairs

Placing devices on the global market is associated with various regulatory hurdles. Be prepared for the different requirements.

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