The ISO 14644 family of standards serves as a comprehensive guide for establishing and maintaining cleanroom environments, especially in the manufacturing of sterile devices. ISO 14644, in particular, is an

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

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

In the last years, the reprocessing of medical devices started to play a critical role and additional requirements have been requested by competent authorities and regulators to ensure the safety

IEC 62304:2006 is an internationally recognised medical device standard which provides a framework for the development, testing and maintenance of software used as or within medical devices. It