Safety, Security & Privacy Compliance
CardioMood partners with certified technology providers to deliver safe, secure, and reliable medical-grade health monitoring solutions.
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CardioMood's wearable devices and cloud infrastructure are developed and manufactured by Corsano Health, a certified medical device company. The following certifications apply to our technology platform.
Quality Management Systems
ISO 9001
Quality Management
International standard for a quality management system to provide products and services that meet customer and regulatory requirements and to demonstrate continuous improvement.
ISO 13485
Medical Devices – Quality Management
Quality management system requirements necessary to provide medical devices and highest quality, meeting customer requirements and complying with medical regulations.
ISO 27001
Information Security Management
Information security management standard necessary to provide the highest levels of confidentiality, integrity, and availability of information.
Medical Device Standards
ISO 14971
Medical Device Risk Management
Process for risk management of medical devices, hardware and software.
IEC 62304
Medical Device Software
Processes, activities and tasks for the efficient and safe life cycle of medical device software.
IEC 62366-1
Medical Device Usability
Process to develop, and evaluate the usability of a medical device, ensuring it is efficient and safe.
ISO 60601
Medical Electrical Equipment
Basic safety and essential performance of medical electrical equipment.
Radio & Electromagnetic Compliance
RED (2014/53/EU)
Radio Equipment Directive
Establishes a regulatory framework for placing radio equipment on the market.
EN 301 489-01/17
Electromagnetic Compatibility (EMC)
Establishes the general technical requirements and test methods for EMC of radio equipment.
EN 300 328 V2.2.2
Wideband Transmission Systems
Requirements and test methods for Wideband transmission systems operating in the 2.4 GHz band.
EN-IEC 61000
EMC Testing & Measurement
Establishes testing and measurement techniques to ensure the immunity and safety of the device against Electrostatic Discharges (ESD), conducted and radiated emissions.
EN 55011 CISPR 11
Radio-Frequency Equipment
Establishes standards for methods of measurement for industrial, scientific and medical radio-frequency equipment.
Cyber Security
EN 303645
IoT Cyber Security
Cyber security requirements for Internet of Things.
UL 2900
Software Cyber Security
Cyber security requirements for network-connectable products, including medical devices and healthcare systems.
Data Protection & Privacy
GDPR
General Data Protection Regulation 2016/679/EU
A regulation in EU law on data protection and privacy in the European Union and the European Economic Area. It also addresses the transfer of personal data outside the EU and EEA.
HIPAA
Health Insurance Portability and Accountability Act
A United States federal statute that stipulates how personally identifiable information, maintained by the healthcare and healthcare insurance industries, should be protected.
Questions About Our Compliance?
For more information about our certifications and compliance documentation, please contact our team.
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