Abstract
The importance of medical devices in everyday users/patients lives is imensse. This is the reason why emphasis must be put on safety during their use. Satisfactory safety level can be achived by implementation of quality and risk management standards. Medical device manufacturers must learn to deal with the potential risks by using theoretical and practical examples and measures in order to protect their users/patients and themselves from suffering huge losses arising from adverse events or recall of their products. The best moment for implementation of risk management methods and analysis begins from the device design and development through manufacturing, sales and distribution. These way medical device manufacturers will succseed in protecting their users/patients from serious adverse events and at the same time protect their brand and society status, while minimizing economic losses
Highlights
Medical devices are vital and integral part of the healthcare system
In 2003, 27% of the adverse events accounted for Class III medical devices, by 2009 this figure increased to 40%
Incomplete FMEA focused on process, not design Regulatory affairs views all change as risk Design validation often complaint but inadequate analysis in order to determine whether a medical device will provide more benefit than harm
Summary
Medical devices are vital and integral part of the healthcare system. They have an enormous impact on everyday life quality of all users/patients. Because of this, their safety, quality and efficacy must be assured. Most of the problems that appear cannot be detected until the medical device is placed on the market and used by a patient/user. Some of the problems that appear can be detected so early, for example, during the design phase
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