CE

The Conformité Européenne (CE) Mark is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985.

The entire portfolio of StrokeViewer is CE marked (BSI; Notified Body number: 2797).

MHRA

The UK Conformity Assessed (UKCA) mark is the mandatory conformity marking for goods placed on the market in Great Britain, introduced following the UK’s departure from the European Union. It replaces the Conformité Européenne (CE) mark for most products, although CE marking may still be recognized in certain cases. The Medicines and Healthcare products Regulatory Agency (MHRA) oversees the regulation of medical devices in the UK, requiring compliance with UKCA marking requirements for market access.

The entire portfolio of StrokeViewer is UKCA marked (BSI; Approved Body number: 0086).

US FDA

The US Food and Drug Administration (FDA) oversees medical devices sold within the United States of America.

Within StrokeViewer’s portfolio, mobile DICOM viewer, LVO triaging, Hemorrhage triaging and Perfusion are FDA cleared.

TGA

The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating therapeutic goods, including prescription medicines, vaccines and medical devices.

The entire portfolio of StrokeViewer is entered in the Australian Register of Therapeutic Goods (ARTG).

MEDSAFE

The New Zealand Medical Devices and Medicines Safety Authority (MedSafe) acknowledges TGA registration and CE marking for medical devices imported to New Zealand.

The entire StrokeViewer portfolio is notified to MedSafe’s WAND database.

TAIWAN FDA

The Taiwan Food and Drug Administration (TFDA) oversees medical devices sold in Taiwan. 

The entire StrokeViewer portfolio is TFDA cleared.

THAI FDA

The Thai Food and Drug Administration (FDA THAI) oversees medical devices sold in Thailand. 

Within the StrokeViewer portfolio, the StrokeViewer AI portfolio is registered with THAI FDA.

CDSCO

The Central Drugs Standard Control Organization (CDSCO) oversees medical devices sold in India.

Within the StrokeViewer portfolio, the StrokeViewer AI portfolio is registered with CDSCO.

Swissmedic

The Swiss Agency for Therapeutic Products (Swissmedic) acknowledges CE marking for medical devices sold in Switzerland.

Within the StrokeViewer portfolio, the StrokeViewer AI portfolio is registered with Swissmedic.

BSI

ISO 13485:2016 specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Nicolab’s quality management system is ISO 13485:2016 certified.

ISO/IEC 27001:2022 is an international standard on how to manage information security. It details requirements for establishing, implementing, maintaining and continually improving an information security management system (ISMS) – the aim of which is to help organizations make the information assets they hold more secure. In addition, NEN 7510-1 is a Dutch standard specifically focused on information security in the healthcare sector. It builds upon ISO/IEC 27001 principles, adding requirements tailored to the protection of medical and personal health information, ensuring compliance with sector-specific risks and regulations.

Nicolab’s information security management system is ISO/IEC 27001:2022 and NEN 7510-1:2017+A1:2020 certified.