In the ISO 13485:2016 standard is written what should be

This chapter of the standards explains how one medical device

The purpose of the requirements review related to the product

The ISO 13485 standard requires the medical device company to

Infrastructure in ISO 13485 is meant workspaces, process equipment, buildings,

This part of the standard explains how employees whose actions

The new version of the ISO 13485:2016 standard expects companies

A quality manual is a document that outlines the company’s

Quality systems, like everything in the regulatory world, have a