Noser Engineering AG Expand Medical Device Technology Offering Meeting the Needs of Global Regulatory Compliance and Accelerating Time to Market
WINTERTHUR, Switzerland, November 19, 2013 /PRNewswire/ --
Noser Engineering Launch End-to-End Lifecycle Medical Technology Engineering Solutions Across a Range of Class I, IIa, and IIb Devices.
Noser Engineering AG, the Swiss-based global information technology consultancy, announced today the expansion of 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 ten 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.
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"Software is emerging as a key differentiator within the global healthcare and medical device technology markets," said Daniel Bruengger, General Manager, Noser Engineering Winterthur. "The sector requires a high degree of visualization, perfection and performance, as well as attractive and accessible user interfaces."
Noser Engineering has expanded its Medical Technology offering to 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.
"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 AG. "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."
Noser Engineering AG 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.
Noser Engineering develop electronics according to the general standard IEC 60601-1 as well as the applicable collateral standards IEC 60601-1 x. Where necessary or appropriate, methods of functional safety according to IEC 61508 can also be implemented to achieve and demonstrate the integrity of the required safety levels.
Project Management, Quality Management and Risk Management are executed applying V-Modell and SCRUM for project management, ISO 13485 for quality management, and ISO 14971 in support of risk management with FMEA, PHA or FTA.
About Noser Engineering AG:
Noser Engineering AG provide information technology consulting, solutions and services to local, European and multinational companies. Swiss ICT Champions, an award winning Microsoft ALM consultancy, founding member of the Open Handset Alliance (Android), leader in Swiss System Testing/QA, and over 29 years of embedded experience, Noser Engineering are members of the Noser Group of companies. http://www.noser.com
Contact:
Anderton Boyd Ltd for Noser Engineering AG
Tammara Anderton
[email protected]
Tel.: +41-(0)44-586-1149
SOURCE Noser Engineering AG
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