Emmet Tobin

Medical Engineering Pocket Book Emmet Tobin

With the success of the "Medical Device Engineers Handbook", ValidationResources.org has created a compact, pocket book version containing all the required content for the Medical Engineer. An ideal pocket resource for engineers working in the medical device industry. This all-in-one reference-style book serves 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. 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 300 pages)