Compliance

NICO.LAB and its products are compliant with standards for quality, safety and security.

Certifications

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 mark indicates conformity with health, safety, and environmental protection standards.

LVO Detection & Location, Hemorrhage Detection

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

LVO Detection & Location, Hemorrhage Detection

FDA
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.

LVO Detection

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.

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.