Bob Parsons has over 28 years of experience in quality systems, regulatory compliance, programme management and product development within the FDA regulated medical device, pharmaceutical and biotechnology industries. His quality assurance expertise includes certification as a lead auditor, performance of quality system gap assessments, system enhancements, alignment and implementation of all quality elements including design controls, risk management, purchasing controls, change control and post-market surveillance. Regulatory experience includes; ISO 13485, 9001 and 14971 certifications, providing guidance for FDA and CE clearance and a designated management representative as well as company representative and lead interface during FDA and ISO audits. He has extensive experience in 483 and warning letter resolution and working within consent-decree environments.