Consultant for Medical Device Software and Compliance and ValidationFDA and ISO compliance, particularly for medical devices and related software systems.Quality system auditing.Supplier quality assurance, audits and FDA checks compliance.Software verification and validation.Software project management.Process assessments and improvement.Computerized systems validation.Software risk management.Software life cycle documentation.Quality system training.Independent ConsultantAbbott Laboratories Diagnostic Division, Irving, TX, 1986 - 2009Manager, Division Software Quality Ass...