Revisions to the Ethylene Oxide & Radiation Sterilization Standards - Gap Analysis: An Easy Guide to What Every Medical Device Manufacturer and Auditor Should Know

The EO and Radiation standards are widely used in the medical device manufacturing industry and have recently been revised. It is imperative that manufactures and sterilization subcontractors perform a gap analysis and implement the requirements of the revised standard in order to ensure worldwide regulatory compliance. This book is intended to provide an easy guide to understanding what a medical device manufacturer is required to do to implement the changes.