Amended Pharmaceutical Affairs Law
The Amended Pharmaceutical Affairs Law was enacted in November 2013, otherwise known as the "Law on Assuring the Quality, Efficacy, and Safety of Pharmaceutical Products and Medical Devices (Pharmaceutical Product and Medical Devices Law)." Among other things, this brought into its purview the approval and certification of the production and sale of standalone software.
 Medical and automotive sectors
In the automotive sector, the international standard for assuring the quality and safety of electronic control systems, ISO26262, was ratified in 2011. In the medical sector, the standard for safety in software in medical devices, IEC62304, was ratified in 2006.
 Development process
The phases of developing a product. Includes a basic design phase, detailed design phase, development phase, testing phase, etc.
 Model-based development
A design method in which the design is described not using natural language but using a model (objects). By conducting simulations from the earliest stages of development, it is possible to uncover design defects, and to automatically generate source code from the model.
Fujitsu is the leading Japanese information and communication technology (ICT) company offering a full range of technology products, solutions and services. Approximately 162,000 Fujitsu people support customers in more than 100 countries. We use our experience and the power of ICT to shape the future of society with our customers. Fujitsu Limited (TSE: 6702) reported consolidated revenues of 4.8 trillion yen (US$46 billion) for the fiscal year ended March 31, 2014. For more information, please see http://www.fujitsu.com.
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Date: 25 June, 2014
Company: Fujitsu Limited, Fujitsu Systems West Limited