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Risk Management for Medical Device Manufacturers: [MD and IVD]
Risk Management for Medical Device Manufacturers: [MD and IVD]
Risk Management for Medical Device Manufacturers: [MD and IVD]
Ebook275 pages2 hours

Risk Management for Medical Device Manufacturers: [MD and IVD]

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About this ebook

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.
LanguageEnglish
Release dateJan 20, 2022
ISBN9781636940144
Risk Management for Medical Device Manufacturers: [MD and IVD]
Author

Joe W. Simon

Growing up in International Falls, Minnesota (“the icebox of the nation”), Joe started his studies at St. Olaf College but transferred to Bemidji State University where he earned his bachelor of science degree in chemistry (with honors). He later earned a master of business administration (MBA) degree through Jones International University. He has been a member of the American Society of Quality (ASQ) since 2008. Starting out as a bench chemist performing environmental and nutritional labeling testing, Joe rewrote almost every analytical method he touched and developed a few new ones. It was during this time that he learned the importance of accuracy, linearity, range, and (especially) system suitability (for example, reagent blanks, matrix blanks, duplicate samples, blank-spikes, matrix spikes, check samples, etc.) for a test method. He also performed minimum detectable limit (MDL) studies for a battery of herbicides and pesticides. This also introduced him to the concepts of good laboratory practice (GLP) and FDA requirements. He eventually transitioned into pharmaceutical quality assurance and quality control. Working for five years at a pharmaceutical company that was under the FDA’s Application Integrity Policy (AIP), he learned the importance of being transparent with your quality problems and your processes. During his time in pharma, he became familiar with AQL sampling tables and started developing quality trending and metrics. In 2005, Joe started consulting, and his first project was helping a large, multinational medical device manufacturer build process FMEAs for all its products. In the intervening years, he worked with numerous companies to build or improve their complaint analysis, trending, postmarket surveillance (PMS), nonconformance (NC), corrective action/preventive action (CAPA), stewardship, and risk management processes. With more than 25 years of experience, Joe recently retired from consulting. As a manager, he was responsible for direct management of the consulting personnel as well as ensuring the competency, quality, experience, project management, and service excellence of the engagement teams. He helped many companies by teaching them how to be more compliant and efficient. Now that he’s retired, he gets to enjoy spending more time with his family.

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