The Medical Device Engineers Handbook

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 PlanningRisk ManagementFacilities and Utilities ValidationEquipment and Software ValidationProcess ValidationPackaging ValidationTest Method Validation21 CFR Part 11 Electronic RecordsMeasurementGood Manufacturing PracticesISO 13485 Lean BasicsSix Sigma Basics Polymer ProcessingToolsUseful References Page Count (Over 200 pages)