S3 Connected Health create and operate safe, secure, and reliable digital health solutions and connected medical devices based on our expertise and compliance with the following regulatory standards where applicable.
ISO 13485 Medical Devices – Quality Management Systems (QMS)
Contract design and development of hardware and software for active medical devices used for diagnosis or therapeutic purposes
ISO 27001 Information Security Management System
for the provision of S3 Connected Health’s Digital Health products and managed services to clients worldwide
ISO 14971 Medical Device Risk Management
Process for risk management of medical devices, including software as a medical device
IEC 62304 Medical Device Software
Processes, activities and tasks necessary for the safe design, and maintenance of medical device software
IEC 62366-1 Medical Device Usability
Process to analyze, specify, develop, and evaluate the usability of a medical device
IEC 82304-1 Health Software
Requirements for the safety and security of health software products
ISO 60601-1 Medical Electrical Equipment
Medical electrical equipment Part 1: General requirements for basic safety and essential performance
Regulation (EU) 2017/745 on Medical Devices (MDR)
Regulation of medical devices for human use and accessories for such devices in the EU
Directive 93/42/EEC concerning Medical Devices (MDD)
Legal requirements for medical devices for human use and accessories for such devices in the EU
UL 2900 Software Cybersecurity
Series of standards with cybersecurity requirements for network-connectable products, including medical devices
Health Insurance Portability and Accountability Act (HIPAA)
A United States federal statute that stipulates how personally identifiable information, maintained by the healthcare and healthcare insurance industries, should be protected
General Data Protection Regulation (EU) 2016/679 (GDPR)
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
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