Healthcare Holding Quality & Regulatory 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.

Lead by an experienced management team

TOUCH

Angelina Hakim CEO
QUNIQUE

TOUCH

Kim Nicolas Züger Director
Effectum CH-Rep

Across a Portfolio of known Brands

eFFECTUM CH-Rep

CH-Rep Service for Foreign Manufacturers of Medical Devices

Effectum CH-Rep AG, based in Olten, provides foreign manufacturers of medical devices with access to the Swiss market by acting as a Swiss authorized representative (CH-REP).

As CH-REP, Effectum CH-REP AG takes on tasks such as ensuring compliance with Swiss registration requirements, cooperating with Swissmedic on preventive and corrective measures, providing a person responsible for regulatory compliance (PRRC), guaranteeing access to technical documentation and reporting incidents and complaints.

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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.

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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.

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.
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.

Our Quality &
Regulatory

We cater to a broad customer base