There are many types of ISO requirements. ISO is an acronym for International Organization for Standardization. The one that Dr. Simon discussed in this weeks lecture refers directly to the application of risk management to medical devices. There are many of these to pick from that I feel are necessary in creating a successful product. ISO 13485 is a document published in 1996 that details the regulatory, and quality requirement for medical devices. Quality of a device is far most one of the key aspects of a successfully selling device. Therefore, a document such as this should be followed whether mandatory, or not. ISO.org has a catalogue in which you can search for specified requirements of certain devices.