Over the course of time, the ISO 2859 standard has established itself as an indispensable tool, not only for medical device manufacturers, but also for a wide range of manufacturing

The MDSAP is an audit program that allows auditing organization to perform a single audit of a medical device manufacturer to obtain a certification that takes in consideration the applicable

The quality manual is one of the most important documents for a company with a quality system in place, and in particular if the company is ISO 13485 certified. ISO

Performing an investigation in case any type of deviation occurs is of fundamental importance nowadays and root-cause analysis methodologies play a fundamental role within the regulated environment. Events and Casual

General Requirements It is important to demonstrate that top management reviews the suitability, adequacy and effectiveness of the organization’s quality system at defined intervals and with sufficient frequency. This is to