Last modified 23-Jul-2024
Compliance
Nicolab and its products are compliant with standards for quality, safety and security.
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.
MHRA
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. Great Britain recognizes the EU’s product conformity assessment mark (CE).
The entire portfolio of StrokeViewer is CE marked.
FDA
The 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.
Within the StrokeViewer portfolio, LVO triaging, LVO localization, Hemorrhage detection, Collaterals, ASPECTS and Perfusion are notified to MedSafe’s WAND database.
TFDA
The Taiwan Food and Drug Administration (TFDA) oversees medical devices sold in Taiwan.
Within the StrokeViewer portfolio, LVO triaging, LVO localization, Hemorrhage detection, Collaterals, ASPECTS and Perfusion are TFDA cleared.
THAI FDA
The Thai Food and Drug Administration (FDA THAI) oversees medical devices sold in Thailand.
Within the StrokeViewer portfolio, LVO triaging, LVO localization, Hemorrhage detection, Collaterals, ASPECTS and Perfusion are registered with THAI FDA.
Swissmedic
The Swiss Agency for Therapeutic Products (Swissmedic) acknowledges CE marking for medical devices sold in Switzerland.
Within the StrokeViewer portfolio, LVO triaging, LVO localization, Hemorrhage detection, Collaterals, ASPECTS and Perfusion are 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 27001:2013 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.
Nicolab’s information security management system is ISO/IEC 27001:2013 certified.