| Abstract: |
This
paper examines safety aspects of medical devices such as: electronics,
software, biological, toxicological, physiological, environmental,
and even psychological factors. The views of different regulatory
bodies in the world on approvals of medical devices are compared
and contrasted. Examples of tradeoffs in design of medical devices
and issues that face medical device engineers are presented. Risk
assessment and mitigation techniques are discussed. Also, legal
aspects of medical device safety are visited.
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