Medical Devices
MDR (EU) 2017/745
Comprehensive regulatory support for Class I to Class III medical devices — from CE conformity assessment to post-market surveillance.
Service portfolio
End-to-end regulatory services
European Authorised Representative
Legal EU representation under MDR & IVDR — EUDAMED-registered SRN, active since 1995.
UK Responsible Person
MHRA registration and UKCA marking support from our Oxford office, established January 2021.
Strategic Regulatory Consulting
CE conformity assessment, technical documentation, clinical evaluation and risk management — strategic and hands-on.
Quality Management Systems
QMS implementation per EN ISO 13485:2016, CAPA processes and notified-body audit preparation.
Industries we serve
Regulatory expertise across healthcare
In Vitro Diagnostics
IVDR (EU) 2017/746
Specialised consulting for IVD manufacturers navigating IVDR classification and compliance pathways for the European market.
Pharmaceutical & Biotech
Strategy & QMS
Regulatory strategy and quality management support for pharmaceutical and biotechnical industry partners worldwide.
Not sure which service fits your project?
Tell us about your devices, target markets and timelines — we’ll map the right combination of services to get you market-ready.
Global network
Local partners in 12 jurisdictions
