QualityMedDev

The Declaration of Conformity is one of the key document asked to be prepared by medical device manufacturer in order to declare the compliance of their products and related quality

The ISO 11135 defines the requirements associated to the development, validation and routine control of the process of sterilization with ethylene oxide. The sterilization of medical device products with ethylene oxide

Quality agreement is one of the most important documentation in a context of medical device quality management system, including QMS requirements for EU MDR 2017/745.  The ISO 13485:2016 specifically requires to

The software development life cycle is one of the key methodology used to manage software.  In recent years, there has been a huge increase of software applications and, specifically, in the

In recent years, the number of medical devices designed to be used  within a home environment has increased substantially; this is why it has been necessary the introduction of a