Risk management for medical device manufacturers / Joe Simon.

Format:

Book

Author/Creator:

Simon, Joe (Joseph John), author.

Language:

English

Subjects (All):

Medical instruments and apparatus--Safety measures.

Medical instruments and apparatus.

Medical instruments and apparatus industry--Risk management.

Medical instruments and apparatus industry.

Medical instruments and apparatus--Quality control.

Physical Description:

1 online resource (231 pages) : illustrations

Place of Publication:

Milwaukee, Wisconson : ASQ Quality Press, [2022]

System Details:

Mode of access: World Wide Web.

Summary:

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 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.

Contents:

Risk management for medical device manufacturers, [MD and IVD]

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.

Notes:

Includes bibliographical references and index.

Description based on print version record.

ISBN:

9781636940403

1636940404

9781636940144

1636940145

9781523146499

1523146494