There is a new draft for vote of ISO 13485 Medical Devices – Quality Management systems – requirements for regulatory purposes. This version updates the references to ISO 9001 to the 2008 version. Some new requirements include:
- A requirement for a risk management process has been added in the product realization phase and ISO 14971 and IEC 62304 have been referenced for guidance.
- The organization also now has to define a method for protecting confidential health information that may be provided as part of the requirements related to the product or as customer feedback or post-market surveillance.
- If required by regulation, the organization shall establish and maintain a system to assign a Unique Device Identifier (UDI) to the device.
- A new requirement for documenting procedures for the validation of the application of computer software used in the quality management system, including production and service provision, has been added.