Medical device publications
Interpharm Press is introducing medical device publications at MD&M. FDA Inspections: A Guide for Medical Device and Diagnostic Manufacturers by John Adcock will be featured. It provides a step-by-step guide for medical device and diagnostic product manufacturers on preparing and passing an FDA inspection, and it helps ensure compliance with FDA laws, rules, and regulations.
The Practical Guide to GMP`s for Device and Diagnostic Manufacturers, by Steven Kuwahara identifies the documentation or standard operating procedures required for compliance with the new device GMPs, ISO 9000, and EN 46000. It describes methods used to classify, store, retrieve, and prepare documents critical to the proper operation of a quality system.
Interpharm Press, Buffalo Grove, IL