As the medical device industry faces the emergence and convergence of several co-integrated standards and regulations, this Handbook serves to provide readers with practical tools and guidance on risk management, process validation, test method validation, six sigma design concepts, and more, with a healthy dose of real-life case studies to aid in the application of the principles herein to your daily practice.

This handbook, edited and spearheaded by Roberta Goode, MSBE CQE, will help you improve the quality of life for customers and their patients. Dive into important how-to information and engaging case studies, designed by preeminent thought leaders in the industry.

Titles and Authorship:

Preface

Roberta Goode

At-A-Glance Steps for Bringing Medical Devices from Concept to Commercialization

William Knab

Robust Design Methodology Using Attribute Data in Product/Process Design

Matt Hedrick

Design for Manufacturability and Assembly (DFMA)

Asmita Khanolkar

Protecting Your Innovations: Patent Protection

David Metzger

Verification and Validation for Use in the Medical Device Industry

Denise Dion

The Application of Risk Management to Process Validation, Supplier Controls, and CAPA

Edwin Bills

Conducting Test Method Validation

George Omae

Best Practices for Documenting Objective Evidence of Verification & Validation

Carrie Keuhn and Atif Yarimci

Principles of Process Validation

Roberta Goode

Equipment Validation: An Iterative Process

Nathaniel Wallis

Validation of cGMP-Regulated Software – “In-Product," "As-Product," "Process/Equipment," and "QMS"

John Lincoln

Case Study: Risk Management for Medical Devices —Theory Behind Tools

Darin Oppenheimer and Suraj Ramachandran