Medical Device Services

We offer comprehensive regulatory support for medical device companies to ensure compliance with global regulations and streamline market entry across major regions including the EU, UK, GCC, Africa and beyond.

Our services include:

• Regulatory intelligence for medical devices
• Registration of medical devices in regions (EU, UK, GCC, Africa, Canada, Australia & NZ).
• Regulatory strategy and device classification guidance (EU MDR, UK MDR 2002 (as amended), IVDR, GHTF, etc.)
• Preparation and submission of technical documentation and design dossiers
• EU Authorised Representative & UK Responsible Person (UKRP) Services
• UKCA and CE Marking support and Notified/Approved Body Coordination
• MHRA (DORS) and EUDAMED Registration Support
• Clinical evaluation report (CER) writing and review
• Post-market surveillance (PMS) and vigilance reporting compliance
• Labeling, UDI, and IFU Compliance & Translations
• Gap analysis and remediation for transitioning from MDD to MDR