QUALITY & REGULATORY MANAGEMENT OF MEDICAL DEVICES We assist Medical Device & In-Vitro Diagnostic Device companies to comply with appropriate regulations.  Our regulatory support covers U.S., European & Canadian requirements & includes the following activities: Device submissions for FDA (510(k) & PMA) & EU CE Mark marketing clearances. (See flowchart) FDA QSR, ISO 9001, ISO 13485 & Canadian compliant quality systems. Manufacturing control systems & audits to ensure regulatory compliance. Responses to FDA 483 reports & warning letters. On site client training in quality & regulatory compliance. Develop, establish, implement & re-engineer quality management systems customized to client needs. Provide training & friend of the company audits prior to regulatory agency inspections. Assist with process & equipment validation planning & practice. Advice on labeling to satisfy U.S., EU & Canadian regulations. Advice on sterilization processing, validation & documentation. Conduct audits of suppliers & contract manufacturers to FDA & ISO requirements. Develop & implement risk management systems to ISO 14971 requirements.   For more information regarding this service and others, please contact us IN THE U.S.: Phone: 888-326-3311 Fax:     972-446-6622 E-mail: Webmaster IN THE U.K.: Phone: +44 (0) 1243 779550 Fax:     +44 (0) 1243 781563 E-mail: bpearce@shotcarr.com