Regulatory Compliance

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

Quality management system requirements necessary to provide medical devices and related services that consistently meet customer and applicable regulatory requirements

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 S3CH
ISO 14971 Medical Device Risk Management

Process for risk management of medical devices, including software as a medical device

IEC 62304 S3CH
IEC 62304 Medical Device Software

Processes, activities and tasks necessary for the safe design, and maintenance of medical device software

IEC 62366-1 S3CH
IEC 62366-1 Medical Device Usability

Process to analyze, specify, develop, and evaluate the usability of a medical device

IEC 82304 S3CH
IEC 82304 Health Software

Requirements for the safety and security of health software products

ISO 60601 S3CH
ISO 60601 Medical Electrical Equipment

Basic safety and essential performance of medical electrical equipment

(EU) 2017745 S3CH
Regulation (EU) 2017/745 on Medical Devices (MDR)

Regulation of medical devices for human use and accessories for such devices in the EU

9342EEC S3CH
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 S3CH
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