Medical device consulting specializing in Risk Management/ Analysis, Design Controls, Post Market Surveillance/ Complaint Handling, CAPA and Quality System Compliance. Working knowledge of Food and Drug Administration CFR’s (cGMP - 21 CFR Part 820, Quality System Regulation and 21 CFR Part 803, Medical Device Reporting and 21 CFR Part 806, Medical Device Corrections and Removals) ISO 13485, ISO 14971, ISO 5840, MDD, CMDAS, PMDA and other regulations in application to risk management, design controls, complaint handling, Corrective/Preventive Actions and quality system compliance for medical devices. Rick Erickson, P.E. Principal and Founder www.linkedin.com/in/rickerick