Quality Assurance & Regulatory Affairs Professional, Lead Auditor and Microbiologist working in the field of Medical Devices and Cleanrooms for 20 years. Currently Managing Director of Maetrics Ltd (Formerly High Edge Consulting) providing consultancy Services covering Quality Systems in ISO 9001 and ISO 13485, Regulatory Affairs – CE marking IVDs and all classes of Medical Devices, 510(k) Submissions, Contamination Control, Microbiology, Sterilisation, Validation and Training. Extensive experience in regulatory audits received from various European Notified Bodies and US FDA Inspections. Routinely plans and implements Quality Management Systems for clients and perform supplier approval and monitoring audits on behalf of clients. Routinely authors product Technical Files and obtain CE marking for IVD and Medical Devices. Sectors/product manufacturers represented include: cleanroom apparel; drapes; procedure packs; infusion lines; ophthalmics; hernia repair; cryogenics; disinfectants, disinfectant wipes; contamination control products; decontamination of re-useable devices; oxygen generator; infant anti-reflux device, cancer detection IVD, mammary implants, proctoscope & rectal mucosal cell sampling device, aortic stents; fibrillation catheter, orthopaedic implants; packaging operations; filters; SSD units. Previous roles include Quality Management, Cleanroom Consultancy, Quality Systems Consultancy, Sterilisation with Gamma Irradiation, Sterilisation using Ethylene Oxide and Laboratory Management
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