ISO 13485:2016 Medical Devices Quality Management Systems
Safety and quality are non-negotiable in the medical devices industry. Healthy.io has implemented a Quality Management System (QMS) according to the ISO 13485:2016 standard, designed to be used by organizations involved in the design, production, installation, and servicing of medical devices and related services.
To check the effectiveness of the system, Healthy.io undergoes initial certification audits, annual surveillance audits, and unannounced audits. In addition, Healthy.io implements internal audits multiple times a year that focus on software-related activities and manufacturing.
The ISO 13485:2016 standard is an effective solution that helps meet the comprehensive requirements for a Quality Management System (QMS). Adopting ISO 13485 provides a practical foundation to address Medical Device directives, regulations, and responsibilities and demonstrates a commitment to the safety and quality of medical devices.
Healthy.io maintains a Quality Management System (QMS) as required by the United States Food and Drug Administration (FDA).