Is ISO 13485 software required?

ISO 13485 establishes requirements for a quality management system, but it does not require organizations to purchase a particular software platform. An eQMS can help organizations manage the processes, documents, records and workflows used to support conformity with the standard.

Does ISO 13485 require software validation?

ISO 13485 includes requirements for validating software used in the quality management system and certain other quality-related applications. Validation activities should be appropriate to the risk associated with the software's intended use.

What processes can ISO 13485 software manage?

Depending on the platform, ISO 13485 software can support document and record control, employee training, CAPA, nonconformance, audits, risk management, supplier quality, complaints, change control, equipment management and other quality processes.

What is the difference between ISO 13485 software and general QMS software?

General QMS software may support many of the same fundamental quality processes. Software used by medical device organizations should also be capable of supporting the controls, documentation, traceability, risk management and applicable regulatory requirements relevant to an ISO 13485 quality management system.

Can ISO 13485 software support multiple locations?

A QMS platform with multi-site capabilities can help organizations establish common quality processes while maintaining appropriate controls, responsibilities and records across different facilities. Organizations should evaluate whether the software can accommodate the structure and requirements of each location.