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:
At-A-Glance Steps for Bringing Medical Devices from Concept to Commercialization
Robust Design Methodology Using Attribute Data in Product/Process Design
Design for Manufacturability and Assembly (DFMA)
Protecting Your Innovations: Patent Protection
Verification and Validation for Use in the Medical Device Industry
The Application of Risk Management to Process Validation, Supplier Controls, and CAPA
Conducting Test Method Validation
Best Practices for Documenting Objective Evidence of Verification & Validation
Carrie Keuhn and Atif Yarimci
Principles of Process Validation
Equipment Validation: An Iterative Process
Validation of cGMP-Regulated Software – “In-Product," "As-Product," "Process/Equipment," and "QMS"
Case Study: Risk Management for Medical Devices —Theory Behind Tools
Darin Oppenheimer and Suraj Ramachandran