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FDA

As a medical device manufacturer and distributor of medical devices in the United States, federal regulations require Healthy.io to comply with the applicable parts of 21 CFR 820.

Healthy.io maintains a Quality Management System (QMS) as required by the United States Food and Drug Administration (FDA) and implements a Quality System consistent with the Quality System Regulation 21 CFR 820 and conducts operations relative to software devices’ premarket development and post-market maintenance. 

The Healthy.io Secure System Development Life Cycle (Secure SDLC) incorporates industry best practices, including formal design reviews by the Healthy.io Security team, threat modeling, and completion of risk assessments. For additional details, refer to ISO/IEC 27001:2013 standards, Annex A, domain 14. An independent auditor has validated and certified that Healthy.io aligns with ISO/IEC 27001:2013 certification standards for Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes.

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).

ISO 13485:2016 Medical Devices Quality Management Systems

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