QualityMedDev

In this specific moment where the new EU MDR 2017/745 is officially entered into force, the management of the so-called legacy devices play a fundamental role from regulatory standpoint. In this

Implantable medical devices are usually highly risky devices for which a potential failure may cause serious consequences to the patient. This is the reason why a great attention has been

The concept of custom-made devices is surely not new and many competent authorities have specific requirements in place to regulate the manufacture and distribution of these types of medical devices.

Several new requirements and topics have been introduced in medical device regulations, emphasizing the importance of specific minimum essential product characteristics; in this context GSPRs (General safety and performance requirements),

The requirements for customer related process are reported in the section 7.2 of the ISO 13485:2016. Customer related processes are highly linked with other processes of the quality system, such