scope:

This document provides guidance on integration of Microbiological Quality & Sterility Assurance (MQ&SA) into the end-to-end process. This framework is intended to connect the MQ&SA activities that should be addressed throughout the end-to-end process: from defining MQ&SA requirements during R&D through customer receipt and use of the product.

NOTE 1 These principles can be applied to other microbiologically controlled products. For example, certain hand care products, wound dressings, drainage bags, etc.

NOTE 2 While reusable devices are not included in the scope of this document, the general principles of design inputs, design process, design outputs, design verification and design validation can be applied.