Risk Management for Medical Device (MD/IVD) Manufacturers

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 risksUsing consistent language in a holistic, closed-loop risk management system leads to greater efficiencyCreating useable and audit-ready risk documents can support verification/validation (V/V) sampling plansDeveloping labels and instructions can help end-users and patients clearly understand the pertinent risksCreating post-market surveillance (PMS) processes is essential to determine if additional clinical/performance studies are necessaryJoe 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. Cover Title page CIP data Contents List of Figures and Tables Dedication Acknowledgments Preface List of Abbreviations Section 1_Building a Risk Program Chapter 1_The Scope of Risk Management Chapter 2_What is “Risk”? Chapter 3_The Sequence of Events—What to Measure Chapter 4_Control and Monitoring of the Sequence of Events Chapter 5_How to Define Occurrence Criteria in the RMP Chapter 6_How to Define Severity Criteria—A Master Harms List Chapter 7_Establishing Design Inputs and Process Controls Chapter 8_Risk Analysis and Evaluation Section 2_Risk in Verification/Validation Chapter 9_Determining What’s Critical to Quality Chapter 10_AQL or LTPD? Chapter 11_Confidence Chapter 12_Reliability Chapter 13_How to Distribute Samples—The Invalid Assumption Chapter 14_Continued Process Verification Chapter 15_Test Method Validation Section 3_Using Risk Chapter 16_What is the Requirement? Chapter 17_Risk-Based Decisions Regarding the Need for an Investigation Chapter 18_Quality System Nonconformities Section 4_Information for Users/Patients Chapter 19_Two Types of Information Chapter 20_Warnings, Precautions, Contraindications, and Adverse Reactions/Events Chapter 21_Information for Safety and Training Chapter 22_Residual Risk Section 5_Other Information Chapter 23_More Bad Guidance in ISO 14971:2019 Chapter 24_Linking Your FMEAs (NCEAs) Chapter 25_Overlapping Definitions Chapter 26_Quality Data for Post-Market Surveillance Chapter 27_Why Investigations Are Illegal in a Nonconformance Report (NCR) Chapter 28_Don’t Blame the People Chapter 29_Flowcharts Summary of Key Takeaways Checklist of Questions Bibliography Index About the Author 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 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