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Noser Engineering AG Expand Medical Device Technology Offering Meeting the Needs of Global Regulatory Compliance and Accelerating Time to Market
Date:11/19/2013

_Eisenring2">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 winni
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