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oving from strength to strength, M Devices has seen it’s operations expand to include, not only Regulatory Compliance but also the Manufacturing of Medical Devices and Product Distribution. Training in Management & Clinical Audit for Primary Care & Acute Trusts, with offices in the UK, Ireland and China. 

M. Devices activities include product research and development in the fields of Endovascular, Obstetrics, Vascular, Radiology and Paediatrics, with manufacturing facilities based in Asia, and   assembly and sterilisation located in Europe.

Regulatory Compliance activities include annual internal CE Mark auditing for USA & Canadian Medical Device manufactures for their European based Distributors and Subsidiaries.  Our Auditing Team is led by an Experienced US National, who understands American Regulatory Requirements in a European Compliance Setting. M. Devices provides an Authorized Representative Service for non-European manufacturers and a fast track CE Mark Self Certification Registration process with the MHRA. In addition M Devices delivers a high speed FDA Adulterated Product Rescue Service for those unfortunate device manufacturers. M Devices regulatory training covers compiling  CE Mark Design Dossiers, Product Technical Files, Quality Assurance Systems, Microbiology and Clean Room guidance.

Distribution throughout Europe, encompasses new product prospecting with direct sales teams, providing early physicians’ evaluation, leading to a fast & cost effective entry into hospitals in the UK & Eire.