Compliance
Nicolab and its products are compliant with standards for quality, safety and security.
CE
The Conformitè Europëenne (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 Conformitè Europëenne (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, and it is still applicable in Great Britain (England, Wales and Scotland).
The entire portfolio of StrokeViewer is CE marked
FDA
The Food and Drug Administration covers medical devices sold within the United States of America.
Within StrokeViewer’s portfolio,mobile mini-PACs and LVO triaging 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 ARTG (ARTG 312943, ARTG 371774)
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, mobile mini-PACS, LVO triaging, LVO location, Hemorrhage detection, Collaterals and ASPECTS are notified to MedSafe’s WAND database (210121-WAND-6W6EET)
BSI
ISO 13485:2016 specifies requirements for a quality management system 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 ISMS is ISO/IEC 27001:2013 certified