ABSTRACT

Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 Standard certificati

chapter 1|6 pages

Scope

chapter 2|2 pages

Normative References

chapter 3|2 pages

Terms and Denitions

chapter 4|32 pages

Quality Management System

chapter 5|24 pages

Management Responsibility

chapter 6|32 pages

Resource Management

chapter 7|180 pages

Product Realization

chapter 8|72 pages

Measurement, Analysis, and Improvement