Important Information: Processing Delays for mailed orders in July due to the RNC convention and heightened security procedures in Milwaukee. To ensure faster service, we encourage you to submit your order online via our secure payment portal or over the phone by calling 800-248-1946 or 414-272-8575. We apologize for any inconvenience and appreciate your patience.
| Cart Total:
Menu

Featured Book

Featured Book

Mastering Safety Risk Management for Medical and In Vitro Devices

Jayet Moon; Arun Mathew, May 2024

When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product’s life cycle into production and post-market phases. Mastering Safety Risk Management for Medical and In Vitro Devices offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485:2016, ISO 14971:2019, European Union MDR, IVDR, and U.S. FDA regulations (including the new FDA QMSR).

Jayet Moon, CQE, CQIA, and CQSP, has a M.S. in biomedical engineering, a B.S. in electrical engineering, an MBA degree, and is a PMI-RMP, CQI Chartered Quality Professional, ERMCP, and RIMS-CRMP. Moon was awarded the Australian Organization for Quality ‘Passion for Excellence’ Award and was recognized in 2021 as an ASQ ‘40 under 40’ Rising Star. He is a Fellow of International Institute for Safety and Risk Management (FIIRSM) and an industry expert on safety and post-market surveillance. He authored several articles and the Quality Press book, Foundations of Quality Risk Management (2020).

Arun Mathew, CQA, CQE, is the Quality System Owner for Quality Risk Management for AbbVie, Inc. Arun earned an Executive MBA from the Quantic School of Business Technology and a master’s degree from Coventry University in addition to a diploma in electronics. With over 20 years of experience in the medical devices and pharmaceutical industries, Arun has pioneered risk-based approaches in design control, verification and validation, process validation, CAPA, and other quality management systems within organizations. He won the 2022 ASQ Delaware J.M. Juran Award for achievements in quality risk management.

Member Price: $49.00

List Price: $70.00
Mastering Safety Risk Management for Medical and In Vitro Devices







Contact Quality Press

North America: 800-248-1946
Mexico: Mobile/cell 001-877-442-8726;
other phone 001-882-442-8726
All other locations: +1-414-272-8575
Fax: 414-272-1734
Email: [email protected]




Subscribe to Quality Press News

Our monthly e-newsletter

Become an Author

View our proposal guidelines, including current calls for authors.


New to the Store

Best Sellers

New Releases!

 Zero Acceptance Number Sampling Plans, Sixth Edition (H1607)
The ASQ Certified Quality Engineer Study Guide, Second Edition (H1601) 
The ASQ Certified Supplier Quality Professional Handbook, Second Edition (H1605)
The ASQ Certified Six Sigma Black Belt Study Guide, Second Edition (H1600) 
The Quality Toolbox, Third Edition (H1592)
NEW! Mastering Safety Risk Management by Jayet Moon and Arun Matthew (H1641)
Quality Risk Management in the FDA-Regulated Industry, Second Edition (H1636)
 

Coming Soon to Quality Press  

2024 Releases:

Certification Products
The ASQ Certified Pharmaceutical GMP Handbook, Third Edition
The ASQ Certified Six Sigma Green Belt Study Guide, Second Edition (H1604)
The ASQ Certified Software Quality Engineer Handbook, Third Edition
The ASQ Certified Quality Technician Handbook, Fourth Edition

ASQ Products
NEW! Leading a Quality Organization: Supercharging From Your Core
Remote Auditing Fundamentals Pocket Guide (formerly "e-Auditing Fundamentals")
The Internal Auditing Pocket Guide, Third Edition

2025 Releases:

ASQ Products
NEW! Lean Six Sigma Pocket Guide for Young Professionals
NEW! Implementing Quality 4.0 from the Ground Up


Certification Products
The ASQ Certified Supplier Quality Professional Study Guide, Second Edition
The ASQ Certified Quality Inspector Handbook, Fourth Edition
The ASQ Certified Reliability Engineer Handbook, Fourth Edition
NEW! The ASQ Certified Construction Manager Handbook


2026 Releases:

ASQ Products
TQM: Introduction to and Overview of Total Quality Management, Second Edition

Certification Products

On Sale

Featured Advertisers