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Modern Mimari Soyut

Medical Device Regulatory Consulting

Your Trusted Partner for Regulatory Affairs and Market Access in Türkiye

Who we are?

Ardis Consulting, based in Istanbul, is led by an experienced team of regulatory professionals, legal advisors, and sectoral consultants. Our diverse expertise spans Turkish Medicines and Medical Device Agency (TITCK) of Turkish Ministry of Health regulations, Social Security Institution reimbursement, and compliance with EU MDR/IVDR frameworks. 

With an agile, project-based working model and a national network of collaborators, Ardis delivers tailored services to each client, ensuring efficient registration, ongoing compliance, and strategic success in the Turkish market.

Our Services

Turkey Registration Holder (TRH) Services

Medical Device and IVD Registration 

MDR & IVDR Regulatory Compliance Support

Reimbursement Strategy and Support

Post-Market Surveillance & Vigilance Reporting

Support

Regulatory Translations and Submission Dossiers

Market Research and Strategic Consulting

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Business Partnerships

As a sister company of Kardus Medical, we combine regulatory precision with strategic market understanding to guide international manufacturers through the complex Turkish healthcare system.

 

Ardis Consulting acts as a locally operating, commercially independent regulatory partner that collaborates with Emergo’s global regulatory consulting network to deliver services within Türkiye. Emergo by UL

Trusted By:

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Why Ardis Consulting?

Our vision is to redefine business success through trust, setting new standards of excellence and empowering businesses to thrive in a competitive market.

Trustworthy references with global pioneers

*Independent representative of Emergo by UL

Close coordination with local authorities

*TITCK, SGK, and DMO

Cost-effective, modular service packages

*On demand services with field profeciency

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ARDİS CONSULTANCY in Numbers

25+ years

TOTAL EXPERIENCE IN MEDICAL DEVICES AND REGULATORY COMPLIANCE

50+

CONSULTING ENTITIES

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