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armoneee replied to the topic "What is Risk-benefit analysis ?" – 3 years, 9 months ago
@ao242 Looking at patient preference is important in understanding how the risk-benefit assessment impacts patients. Certain patient information is more favorable in testing for the success of the medical device. To better understand if the risks outweigh the benefits certain… Read more»
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thuytienlecao replied to the topic "Design Controls in the other countries" – 5 years, 10 months ago
To add in @ao242 comment about ASEAN Medical Device Regulations, Vietnam is one of the countries that import a lot of medical devices. In the past (before the end of 2016), there were 2 distinct bodies of legislation—one for medical… Read more»
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thuytienlecao replied to the topic Design Controls in the other countries in the forum Introduction to Design Controls 7 years, 5 months ago
To add in @ao242 comment about ASEAN Medical Device Regulations, Vietnam is one of the countries that import a lot of medical devices. In the past (before the end of 2016), there were 2 distinct bodies of legislation—one for medical devices manufactured in Vietnam and the other for imported ones. All domestically manufactured medical devices had t…[Read more]
