Medical Devices Biological Safety Assessment: Towards Animal-free Testing

The SEURAT-1 approach towards animal free human safety assessment.

SEURAT-1 is a European public-private research consortium that is working towards animal-free testing of chemical compounds and the highest level of consumer protection. A research strategy was formulated based on the guiding principle to adopt a toxicological mode-of-action framework to describe how any substance may adversely affect human health.The proof of the initiative will be in demonstr...

Animal-Free Chemical Safety Assessment

The exponential growth of the Internet of Things and the global popularity and remarkable decline in cost of the mobile phone is driving the digital transformation of medical practice. The rapidly maturing digital, non-medical world of mobile (wireless) devices, cloud computing and social networking is coalescing with the emerging digital medical world of omics data, biosensors and advanced ima...

Towards Safety Case Integration with Hazard Analysis for Medical Devices

Safety case is one of system safety lifecycle products and should be consistent with other lifecycle products like hazard analysis results. In this paper we present a method of safety case integration with hazard tables based on the use of parametrized argument patterns. We describe a hazard table metamodel, a safety argument pattern and a mechanism of pattern instantiation using a linking tabl...

Biological safety in the animal laboratory.

The Safety of Medical Devices Containing Dehp-

...................................................................................................................... 4 EXECUTIVE SUMMARY ................................................................................................ 5 1. BACKGROUND...................................................................................................... 11 2. TERMS OF REFERENCE .....................