How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and

This book explains the requirements for compliance with FDA regulations and ISO standards (9001/13485) for documented information controls, and presents a metho

We are in what many call “The Age of the Customer.” Customers are empowered more than ever before and demand a high level of customer attention and service. T

Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves

Standards, Quality Control and Measurement Sciences in 3D Printing and Additive Manufacturing addresses the critical elements of the standards and measurement s