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su65 replied to the topic Discussion Topic: Project Management in a medical device setting in the forum Intro to Project Management 8 years, 4 months ago
Being a project manager for a medical device company is more challenging than a project manager for skyscraper building company. Medical devices should pass the FDA regulations which is more complicated than the regulations followed by a skyscraper building company. Medical device should pass regulations like good manufacturing process (GMPs), good labelling process (GLPs), 510K process, device classification into class 1, 2 or 3 based on the risk possessed by the device on the patients. If the device needs to be tested on humans, then IRB approval has to be obtained before doing clinical trials. Apart from these challenges the other processess almost remain the same for both.