Provides requirements on methods to perform security risk management for a medical device in the con..

This document defines fluid delivery performance test methods that cover the full range of use condi..

This technical information report (TIR) provides guidance to medical device manufacturers, who are r..

Provides guidance for industrial users of moist heat sterilization including the interrelationship o..

This report presents clinical evidence regarding the safety and efficacy of reuse of hemodialyzer bl..

This technical information report (TIR) provides guidance for a comprehensive framework that integra..

This document provides a mapping of the US FDA 21 CFR requirements to the "regulatory requirements" ..

The focus of TIR104 is to provide guidance in managing the process for transferring a health care pr..

This technical information report provides recommendations and processes to assist manufacturers of ..

This document provides guidance regarding the understanding and use of product bioburden data includ..