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asimbana 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
The difference between being a project manager for a medical device project compared to a building/construction project is that in the medical device industry, the project manager must see the project from the start to the end and also follow up afterwards for revisions and initiate risk management. On the other hand the building project manager has the similar life cycle of the project but has a twist, especially when it comes to following regulations and rules, these project managers it seems follows from the start to end of the project but ends at that. Medical device project managers have to follow FDA regulations and processes, if they are a manufacturer as well, they must follow ISO 9001 protocols. On the other hand building project managers have to work with OSHA and Directorate of Construction (DOC) to establish the saftey of the well being of the general public just how FDA protects the consumer’s of such medical devices products. The U.S create these government based organizations branches to regulate and create a gold standard.