Design Controls: Addressing Changes in ISO 13485

When ISO 9001 was produced by the International Standards Organization, it put forth the general quality standard that organizations could adopt to ensure that the organization is focused on quality, the basic structure is in place, and the product it is offering will be at acceptable levels. That was readily accepted and embraced. For the medical device industry, ISO 13485 specifies requirements for a quality management system where a medical device organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.