Add to ORKG190-201The aim of the case study is to reflect on the FDA regulations on the Medical Devices, aspects of classifying the risk caused by the devices and to study the process of recalls by the companies strategically followed by the regulatory authority. Further, a case study was performed to identify the medical devices that were recalled in the year 2020, to investigate the reason for the recall, the subsequent effects on the system and further actions to rectify the problems. The study emphasized various reasons for the medical devices recalled during the year 2020. It warns the companies and users to follow the conditions strictly during their manufacture and trials which would minimize the errors of the functioning of the medical d...
Regulations of medical device plays a very significant role in designing, development and commercial...
On 16 April 2011, the US Food and Drug Administration’s (FDA’s) final rule on medical device data sy...
© Journal of Medical Device Regulation – 2023. This is the accepted manuscript version of an article...
The aim of the case study is to reflect on the FDA regulations on the Medical Devices, aspects of cl...
A letter report issued by the Government Accountability Office with an abstract that begins "Recalls...
According to the Food and Drug Administration (FDA) a recall is the removal or correction of medical...
Background Medical devices are used widely for virtually every disease and condition. Although devic...
According to the Food and Drug Administration (FDA) a recall is the removal or correction of medical...
Background Medical devices are used widely for virtually every disease and condition. Although devic...
According to the Food and Drug Administration (FDA) a recall is the removal or correction of medical...
Medical device manufacturing and distribution is globalised; consequently, medical device failures p...
Testimony issued by the Government Accountability Office with an abstract that begins "The Food and ...
Background: Medical devices are used widely for virtually every disease and condition. Although devi...
Background: Medical devices are used widely for virtually every disease and condition. Although devi...
Background: Medical devices are used widely for virtually every disease and condition. Although devi...
Regulations of medical device plays a very significant role in designing, development and commercial...
On 16 April 2011, the US Food and Drug Administration’s (FDA’s) final rule on medical device data sy...
© Journal of Medical Device Regulation – 2023. This is the accepted manuscript version of an article...
The aim of the case study is to reflect on the FDA regulations on the Medical Devices, aspects of cl...
A letter report issued by the Government Accountability Office with an abstract that begins "Recalls...
According to the Food and Drug Administration (FDA) a recall is the removal or correction of medical...
Background Medical devices are used widely for virtually every disease and condition. Although devic...
According to the Food and Drug Administration (FDA) a recall is the removal or correction of medical...
Background Medical devices are used widely for virtually every disease and condition. Although devic...
According to the Food and Drug Administration (FDA) a recall is the removal or correction of medical...
Medical device manufacturing and distribution is globalised; consequently, medical device failures p...
Testimony issued by the Government Accountability Office with an abstract that begins "The Food and ...
Background: Medical devices are used widely for virtually every disease and condition. Although devi...
Background: Medical devices are used widely for virtually every disease and condition. Although devi...
Background: Medical devices are used widely for virtually every disease and condition. Although devi...
Regulations of medical device plays a very significant role in designing, development and commercial...
On 16 April 2011, the US Food and Drug Administration’s (FDA’s) final rule on medical device data sy...
© Journal of Medical Device Regulation – 2023. This is the accepted manuscript version of an article...