29 Nov 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Noser Engineering is expanding its medical technology offering for end-to-end lifecycle engineering solutions across a range of class I, IIa, and IIb devices. Noser Engineering has been a partner to 10 of the top global medical technology companies headquartered in Switzerland helping them bring numerous products to market while meeting the strictest global regulatory compliance standards.
Noser Engineering expanded offering will provide end-to-end, lifecycle solutions for equipment, hardware and software development, functional safety, project management of medical standards, analysis and requirements engineering, architecture and design, implementation, QA (unit test, integration test, system test), documentation, medical standards training and maintenance and support.
Noser Engineering develops software and electronics for the 93/42/EEC Medical devices directive (MDD) and the 98/79/EC In vitro diagnostic directive (IVDD). Noser Engineering ensures that software fulfills the requirements of the IEC 62304 directives. Usability and system requirements for the specification and implementation of the user interface, as well as testing and validation for use, are implemented in accordance with IEC 62366.
"Software is emerging as a key differentiator within the global healthcare and medical device technology markets," said Mr Daniel Bruengger, GM, Noser Engineering Winterthur. "The sector requires a high degree of visualization, perfection and performance, as well as attractive and accessible user interfaces."
"Embedded software helps companies overcome the challenges of rapid product development, because functionality can be added more quickly to software than to hardware." said Dr Michael Eisenring, manager embedded systems, Noser Engineering. "Innovation, quality and cost-consciousness are all key drivers within global healthcare as are finding the balance between meeting the requirements of global regulatory compliance and accelerating time to market."