Eomi Consultancy provides comprehensive regulatory compliance and quality management solutions to help businesses meet UK and international market requirements. Our expertise covers a range of industries, ensuring seamless product compliance and successful market entry.

Medical Devices UKRP – Acting as a UK Responsible Person (UKRP) for medical devices, ensuring compliance with UK MDR 2002, managing regulatory submissions, and liaising with the MHRA.

Cosmetics UKRP – Providing UK Responsible Person services for cosmetics, including Cosmetic Product Safety Reports (CPSR), SCPN notifications, and regulatory compliance under UK Cosmetics Regulation.

General Safety and Performance Requirements (GSPR) – Supporting manufacturers with GSPR compliance for medical devices and in-vitro diagnostics under the UK and EU regulatory framework.

Personal Protective Equipment (PPE) Compliance – Assisting with conformity assessments, technical file creation, and UKCA/CE marking for PPE products in line with UK and EU regulations.

UKCA & MDR Technical File Development – Preparing technical documentation for UK and EU regulatory submissions, ensuring compliance with evolving medical device regulations.

Regulatory Audits & Competent Authority Reviews – Providing expert guidance on MHRA, Notified Body, and authority audits to streamline approvals and market access.