Regulatory clarity for international MedTech at every stage of the medical device lifecycle
EUMEDIQ provides medical device manufacturers with the regulatory expertise and compliance infrastructure to achieve and maintain compliant market access across the EU, UK, and Switzerland throughout the full device lifecycle.
WHO WE ARE
An internationally
operating service provider for medical device manufacturers
EUMEDIQ is an internationally operating service provider headquartered in Zug, Switzerland, with offices in Hardt, Germany and London, United Kingdom. Our team comprises highly qualified experts with extensive experience across regulatory affairs, quality management, information security, and medical device compliance, working exclusively with medical device manufacturers across the EU, UK, and Swiss regulatory frameworks.
We accompany medical device manufacturers from initial regulatory strategy and market entry through to post-market surveillance and ongoing compliance obligations. Our own management system is operating within the ISO 13485 and ISO 27001 regulatory frameworks, reflecting our commitment to operating at the same standards we set for our clients.
Headquatered in Zug, Switzerland, operating from Hardt, Germany and London, UK.
3 Offices
Total active products across the EU, UK, and Swiss regulatory databases
10,001
Basic UDI-DIs assigned across
our active portfolio under MDR and IVDR
730+
OUR SERVICES
Integrated regulatory services, delivered across the full device lifecycle
EUMEDIQ provides medical device manufacturers with a comprehensive range of regulatory services covering the full product lifecycle, from initial device classification and conformity assessment strategy through technical documentation, clinical evaluation, and post-market surveillance.
Our services extend across authorised representation in the EU, UK, and Switzerland, ISO 13485 and ISO 27001 auditing, quality management system implementation, information security consulting, cybersecurity advisory, and AIMEDIQ, our purpose-built regulatory intelligence platform for the life sciences industry.
Medical Device Consulting
Regulatory strategy, technical documentation, clinical evaluation, and post-market surveillance across the full device lifecycle.
Authorised Representative
Legal representation across the EU, UK, and Switzerland under MDR, IVDR, UKCA, and Swissmedic frameworks.
Auditing Services
Certified lead auditors for management systems in the MedTech industry to ISO 13485, MDSAP and ISO 27001
GLOBAL MARKET ACCESS
Discover new markets and plan your entry with our
Regulatory World Map
The EUMEDIQ Regulatory World Map is a concise guide for medical device manufacturers planning international market entry. It provides a structured, country-by-country overview of regulatory requirements by product class, giving manufacturers the clarity needed to assess new markets before committing to a regulatory pathway.
Identify new expansion opportunities, explore country-specific compliance obligations, and contact EUMEDIQ for tailored regulatory guidance on your specific product and target markets.
KNOWLEDGE
Stay informed to stay compliant in an ever-changing regulatory environment
Regulatory clarity starts with the right information. EUMEDIQ publishes practical guidance, expert analysis, and in-depth content on the regulatory developments and compliance requirements affecting medical device manufacturers across global markets.
Subscribe to our newsletter to stay informed
Subscribe to the EUMEDIQ newsletter for regular regulatory updates, compliance guidance, and expert analysis covering MDR, IVDR, cybersecurity obligations, and the latest developments affecting medical device manufacturers across global markets.