Comprehensive range of regulatory services covering the full product 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
Integrated regulatory services, delivered across the full device lifecycle
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.
SWISSDAMED REGISTRATION
Swissdamed XML by EUMEDIQ
With the 1 July 2026 registration deadline approaching for medical devices in Switzerland, manufacturers face the task of populating swissdamed with complete, schema-compliant product data. Manual entry across large portfolios is slow, error-prone, and consumes regulatory team capacity that should be focused elsewhere. Swissdamed XML by EUMEDIQ transforms existing product data into strictly compliant XML files that meet the swissdamed schema requirements, ready for direct bulk upload to the portal.
The tool is built to handle scale, processing hundreds of datasets in one go and eliminating the repetitive work of single-record submissions. It is available as a per-enterprise licence or on a Basic UDI-DI basis, giving manufacturers flexibility to match the cost model to portfolio size and submission volume. The result is a faster, cleaner route to Swiss market compliance with team capacity preserved for higher-value regulatory work.
Get in touch with us for your project
From early-stage planning to ongoing post-market compliance, EUMEDIQ supports medical device manufacturers at every stage of their project, bringing the regulatory expertise needed to move forward with confidence.
Contact us today and tell us about your next project. We will respond promptly and help you understand exactly what your regulatory pathway requires.
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.
