As a quality professional in the medical device industry, you know all too well the importance of a risk management process-and how iterative it can be. Industry regulations and standards-like ISO 14971-help medical device manufacturers define risk management processes, but they don't make them bulletproof, that is, ensure the efficacy of their products while minimizing future liability. This book can help you build a bulletproof, risk process. You will learn how: Designing product and manufacturing processes controls risks Using consistent language in a holistic, closed-loop risk management system leads to greater efficiency Creating useable and audit-ready risk documents can support verification/validation (V/V) sampling plans Developing labels and instructions can help end-users and patients clearly understand the pertinent risks Creating post-market surveillance (PMS) processes is essential to determine if additional clinical/performance studies are necessary Joe Simon holds an MBA and has been a member of ASQ since 2008. Over his nearly 30-year career, he worked with numerous companies as an employee and a consultant to build or improve complaint analysis, trending, post-market surveillance (PMS), nonconformance (NC), corrective action/preventive action (CAPA), stewardship, and risk management processes.|As a quality professional in the medical device industry, you know all too well the importance of a risk management process-and how iterative it can be. Industry regulations and standards-like ISO 14971-help medical device manufacturers define risk management processes, but they don't make them bulletproof, that is, ensure the efficacy of their products while minimizing future liability. This book can help you build a bulletproof, risk process. You will learn how: Designing product and manufacturing processes controls risks Using consistent language in a holistic, closed-loop risk management system leads to greater efficiency Creating useable and audit-ready risk documents can support verification/validation (V/V) sampling plans Developing labels and instructions can help end-users and patients clearly understand the pertinent risks Creating post-market surveillance (PMS) processes is essential to determine if additional clinical/performance studies are necessary Joe Simon holds an MBA and has been a member of ASQ since 2008. Over his nearly 30-year career, he worked with numerous companies as an employee and a consultant to build or improve complaint analysis, trending, post-market surveillance (PMS), nonconformance (NC), corrective action/preventive action (CAPA), stewardship, and risk management processes.