US-based packaging automation firm QuickPouch has partnered with Finnish production automation solutions supplier Ginolis. The partnership will enable global in vitro diagnostic medical device (IVD) manufacturers to easily integrate their ...
Tags: Packaging, QuickPouch
ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.[1] This ...
Tags: ISO 13485, certification
The biotechnology and personalized medicine company, Epistem, has gained CE mark for its in vitro diagnostic medical device (CE-IVD), Genedrive Tuberculosis (TB) test. Epistem said the registration enables to place its TB test and ...
Tags: Epistem, CE mark, CE-IVD, diagnostic medical device, TB test
Sphere Medical has presented positive results of its in-vitro diagnostic medical device designed for measuring intravenous anaesthetic propofol at the point of care. The device, Pelorus 1500, provides real time measurements of propofol ...
Tags: Sphere Medical, medical device