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1. Burton, J., Mc Caffery, F., and Richardson, I., (2009) “Improving Software Risk Management in a medical device Company”, International Conference on Software Engineering (ICSE) 2009, Vancouver, Canada pp 152 – 162.
2. ISO 14971 (2007) – Medical Devices – Application of risk management to medical devices, Switzerland, ISO.
3. ISO 13485:2003 (2003) Medical devices — Quality management systems — Requirements for regulatory purposes. Second ed. Geneva, Switzerland, ISO.
4. European Council, Council Directive 2007/47/EC (Amendment). 2007, Official Journal of The EuropeanUnion: Luxembourg.