ISO 13485:2016 Certification

Medical Devices Quality Management

ISO 13485 specifies quality-management requirements for organizations involved in the life cycle of medical devices and related services.

Main focus areas

Regulatory-oriented quality controls
Risk-based processes
Supplier control
Validation and traceability
Complaint and feedback handling

Typical value

A structured management or technical standard can help an organization document responsibilities, control key activities, evaluate performance and improve confidence among interested parties. Certification or accreditation requirements vary by standard and scope.