In Part 1, our goal was to create an organizationwide, business-oriented QMS, in which the financial and quality objectives were transparent. The QMS was to be based on the canonical set of ISO 9000 ...

You've developed a great product and feel ready to jump into Japan's medical market. Not so fast. Before you can sell your medical device in Japan, you need to register it. One of the key requirements ...

FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed to prepare industry for the February 2, 2026 effective ...