(CRC Press: Boca Raton, FL) -- Although complex and lengthy, the process of certification to the International Organization for Standardization (ISO) standard, ISO 13485—“Medical devices—Quality management systems—Requirements for regulatory purposes,” can be easily mastered using the simple method outlined in ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry, by Itay Abuhav (CRC Press, 2011).

Written by an experienced industry professional, this practical book is filled with examples drawn from the author’s experience, and spanning different sectors and fields of the medical device industry, the book translates the extraordinary requirements and objectives of the standard into feasible activities and tasks. The book provides a full analysis of each clause and subclause through quality perspectives: the implications of an organization, its processes, management, human resources, infrastructures, work environment, control and effectiveness, documentation, and records.

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