Certifications, Standards and Regulations
Detect and monitor health conditions
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
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 Equipment Directive (RED, 2014/53/EU)
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
Requirements and test methods for Wideband transmission systems operating in the 2.4 GHz band
EN-IEC 61000
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
Establishes standards for methods of measurement for industrial, scientific and medical radio-frequency equipment
EN 303645
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
General Data Protection Regulation 2016/679/EU (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
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