Global Quality Compliance
ISO 13485:2016 certification is a globally recognised industry-grade compliance quality management system for building and consistently meeting the quality requirements of a medical device.
Risk Management Compliance
ISO-14971:2019 risk management compliance demonstrates the risk management capability of wellthy CARE™ to identify, evaluate, estimate and monitor, and control the associated risks across the SaMD lifecycle.
Information Security Management Compliance
ISO 27001:2013 demonstrates Wellthy’s ability in establishing, implementing, maintaining, and continually improving its information security management, and also helps organizations keep information assets secure.
Privacy Information Management Compliance
ISO 27701:2019 is a privacy information management standard (PIMS) and extension of ISO-27001 requirements that demonstrates Wellthy’s ability to manage and process data, and also safeguard the privacy and personally identifiable information(PII).
MDR Risk Classification
wellthy CARE™ platform is classified as low risk intended use SaMD for patients and users by Medical Device Regulation, Europe.
Software Life Cycle Process Management
The wellthy CARE™ platformstrictly adheres to the software lifecycle management process of building Software as a medical device.
Data Protection and Privacy Compliance for Europe
Wellthy Therapeutics is General Data Protection Regulation (GDPR) compliant organization and protects the personal data and privacy of EU citizens for transactions that occur within EU member states.