Owner
CurrentOffering strategic consulting and tactical solutions to understand and overcome the complicated world of Regulation and Compliance, with specialist knowledge of the Medical Device industry including CE marking, Product Compliance and Specific Market Requirements. Over 30 years experience in Class 1, 2 and 3 medical device manufacturing covering NPI, CAPA, market submissions, Complaint & Vigilance, Remediation, Quality Systems, Technical Files, Project Management, Process/Product Auditing, MDR transition and Design Compliance.Previous Contract Customers include Zimmer Biomet (Orthopaedic Implants), ReNeuron (Stem Cell therapy), Stanmore Implants (Orthopaedic Implants), Vascutek (Vascular and Cardiovascular), Thermo Fisher Scientific (IVD), Creo Medical (Surgical Endoscopes), Inotec AMD Ltd (Woundcare) and THOR Photomedicine (LED & Laser Therapy) .
