This book aims to create a new standard resource for engineers working in the medical device industry. The objective was to produce an all-in-one reference-style book serving the needs of engineers at different levels in their career journey. It is based on over a decade of experience working within the industry. It draws not only on this experience but on best practices and widely accepted conventions. These practices and conventions are typically shaped by the demands of regulatory bodies and international organisations. Chapters include:
Design Controls
Validation Planning
Risk Management
Facilities and Utilities Validation
Equipment and Software Validation
Process Validation
Packaging Validation
Test Method Validation
21 CFR Part 11 Electronic Records
Measurement
Good Manufacturing Practices
ISO 13485
Lean Basics
Six Sigma Basics
Polymer Processing
Tools
Useful References

Page Count (Over 200 pages)