Jim is an independent Management Consultant and has been running a private consultancy under the name of QualiMedd for over 18 years. QualiMedd specialise in implementing quality and CE marking / Food and Drug Administration registration in medical devices and in-vitro diagnostics companies of all sizes. Jim trained as a bio-medical engineer and has over thirty years experience in the health care industry

Jim has an MSc in Total Quality Management, holds membership of the Chartered Quality Institute (UK), The British Computer Society, The American Society for Quality (Bio medical and Software divisions) and is both a lead auditor and TickIT software auditor. Qualimedd is active in the promotion of Quality Management Systems and Regulatory Affairs, in ISO 9001 / ISO 13485 / FDA QSR registration and in the Medical Devices Directives / In Vitro Diagnostics Directive.

Having carried out assessments worldwide on behalf of major Assessment Bodies who are also Notified Bodies, Jim is fully aware of their requirements in respect of quality systems and technical & design dossiers with respect to the Medical Devices Directives.
QualiMedd is an independent management consultancy working within the areas of product development and Quality / Regulatory Affairs improvement. We specialise in the medical devices and In-Vitro Diagnostics industries in both development and manufacturing companies and sales and service companies. Our services cover ISO 9001:2000, ISO 13485:2003 and FDA registration.