Inspection verification is a fundamental tool that companies can—and must—adopt to assess whether their Quality Management System (internal audit) or…

The risk management activity should be entrusted to a qualified team formed for this purpose, usually consisting of at least…

The data recording system aims to collect the results of all activities performed, all checks conducted, and the results obtained,…

The ISO 13485 standard establishes that the organization must conduct internal audits at planned intervals: it is good practice to…

MDSAP è un programma di audit che consente la valutazione della conformità del Sistema di Gestione per la Qualità (SGQ)…

What does it imply to outsource the manufacturing process of a medical device to an external supplier? What are the…