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Our Quality &
Regulatory

Specialists in quality management, regulatory affairs, and Swiss market access across medical devices and in-vitro diagnostics
OralHealth Platform
Our Quality & Regulatory Platform brings together specialized Swiss experts supporting MedTech and in-vitro diagnostics companies throughout the product lifecycle. With expertise across MDR, IVDR, MDSAP, quality management systems, regulatory affairs, audits, training, technical documentation, and compliance implementation, we help manufacturers, distributors, and healthcare partners meet complex regulatory requirements with practical, solution-oriented support.

Because safe and successful market access depends on robust quality systems, clear regulatory strategy, and reliable local representation. Across the Quality & Regulatory Platform, we combine consulting expertise, audit and training capabilities, CH-REP services, and scalable compliance structures to support medical device and IVD companies in entering, maintaining, and expanding their presence in Switzerland and Europe — with confidence, efficiency, and regulatory clarity.

>2M Revenue
>60 Customers
>5 Employees

Lead by an experienced management

angelinahakim_foto
TOUCH
Angelina Hakim CEO
QUNIQUE
Angelina Hakim CEO
QUNIQUE

QUNIQUE

Specialist in Quality Management, Regulatory Affairs & Training for Medical & in-vitro-diagnostic Devices

QUNIQUE, based in Wohlen (AG), Switzerland, is a specialized partner for medical device (MD) and in-vitro diagnostic (IVD) companies. The firm supports manufacturers, importers and distributors in meeting regulatory and quality requirements under ISO 13485, ISO 9001, EU MDR (2017/745), IVDR (2017/746) and FDA rules. QUNIQUE provides hands-on guidance in building and maintaining compliant quality management systems, preparing audits, creating technical documentation and ensuring post-market surveillance.

Close collaboration with clients is at the core of QUNIQUE’s approach. The team delivers tailored, practice-oriented solutions rather than generic templates, and can act as Authorized Representative and Importer to enable market access in Switzerland and the EU. Training is another key pillar: QUNIQUE offers targeted workshops and seminars for regulatory, quality and leadership teams to build internal competence and ensure long-term, sustainable compliance.

 

Acquisition & Integration Timeline

We built the Quality & Regulatory Platform by partnering with strong founder-led specialists and then scaling what already works — with technology, shared capabilities, and collaboration across the group.
  • Integration Announcement Effectum CH-Rep

    2026 🚀 Integration

    Effectum CH-Rep, based in Olten, has now been successfully integrated into QUNIQUE, taking our Quality & Regulatory platform to the next level.
  • QUNIQUE HHS Deal Announcement

    2025 🚀 Acquisition

    Acquisition of a stake in QUNIQUE GmbH, a leading ISO 13485-certified consulting firm specialized in regulatory affairs, quality management, CH/EU representation and importer services for medical devices and in-vitro diagnostics.
  • Effectum CH-Rep Deal Announcement

    2025 🚀 Acquisition

    Acquisition of Effectum CH-Rep AG, a Swiss Authorized Representative service provider enabling foreign medical device manufacturers to access the Swiss market and meet local regulatory requirements.

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