The version of 2016 of ISO 13485:2016 has a new requirement compared the previous version which is related to the so-called Medical Device File. The medical device file (MDF) is

Clinical evaluation is the assessment and analysis of clinical data of a medical device to verify its clinical safety and performance. The evaluation is based on a comprehensive analysis of

For medical devices that have to be provided sterile, packaging validation plays an extremely important role. The validation of the packaging processes might involve different players, not only the manufacturer,

Clean room validation is nowadays essential for medical device manufacturers of sterile devices; sterility of the devices has a direct impact on patient safety and product quality. Building a cleanroom

Field safety corrective action is one of the pillar process associated to post-market surveillance and its key importance is related to the impact of this process to the safety of