In this article, we want to give you a deep dive into the requirements associated to the Design and Development Plan. As you know, the Design Process for medical devices

The complaint handling process for medical device manufacturers is of fundamental importance for multiple reasons. Surely, compliant process is directly linked with the safety of the devices on the field

It is impossible to deny the importance of risk management process for medical device organization and the recent publication of the updated version of ISO 24971 is a valuable tool

The 21 CFR 803 is the section of the Code of federal Regulations which regulates the medical device reporting (MDR) according to FDA regulation. We have been trough the

For any type of quality management system, whether within the medical device sector or not, having an established document control process and procedure it is essential. The quality system is