IMed Consultancy Ltd

medical devices

About

IMed Consultancy Ltd is a specialist medical devices regulatory consultancy based in Bloxham, Oxfordshire, UK. Founded in 2012, the company offers expert regulatory affairs and quality assurance services for a range of medical devices, including Class III devices, active and implantable devices, Software as a Medical Device (SaMD), and In Vitro Diagnostics (IVDs). The consultancy supports clients globally, helping them navigate complex regulatory environments to bring medical devices to market and maintain compliance. IMed Consultancy provides a comprehensive range of services throughout the product lifecycle, from concept and design consultancy to post-market surveillance activities. Their expertise includes regulatory affairs consulting, quality systems development, clinical evaluation report preparation, and assistance with global registrations. The company serves a diverse clientele, from large corporations to smaller businesses, emphasizing flexible, client-focused solutions.

Technologies

Outlook MailChimp SPF Google Cloud Hosting Barracuda Networks AI

Keywords

mdr ce marking medical devices in vitro diagnostics auditing mdsap qms fda global registrations clinical evaluations risk management regulatory affairs technical files ivdr iso 14971 21 cfr part 820 iso 13485 health canada 510k tga ivd ukca uk responsible person medical equipment manufacturing regulatory compliance for active devices regulatory gap analysis brazil anvisa field safety corrective actions digital medical devices regulatory strategy

Location

Barford Road, Banbury, England, United Kingdom, OX15 4

Related Companies

Companies in the same industry