The production of medical devices is highly regulated, which is reflected particularly in EU regulations and standards.
If one of these standards is updated in response to rapid progress, it is crucial to react fast and to implement the required changes within the specified period. This has happened again:
The ISO 13485:2016 standard, published on March 2016, constitutes the first major update of one of the fundamental standards governing the production and trial of medical devices in 13 years. The 2003 version, which was valid until the recent update, regulates the requirements for comprehensive quality management systems used in companies developing, producing and marketing medical devices. The revised version has a considerably wider scope: regulations for quality management systems now affect all organizations that play a role in the life cycle of a medical device, including suppliers and service providers. Accordingly, the standard now applies all the way from the brainstorming stage to the disposal of a device.