Items related to Risk Management for Medical Device Manufacturers

Risk Management for Medical Device Manufacturers - Softcover

Joe Simon

 
9781636940137: Risk Management for Medical Device Manufacturers
Softcover
ISBN 10: 1636940137 ISBN 13: 9781636940137
Publisher: ASQ Quality Press, 2022

Synopsis

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

"synopsis" may belong to another edition of this title.

About the Author

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.

"About this title" may belong to another edition of this title.

Publisher
ASQ Quality Press
Publication date
2022
Language
English
ISBN 10 
1636940137
ISBN 13 
9781636940137
Binding
Paperback
Edition number
1
Number of pages
258