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There is a mountain of information on FDA regulation and compliance for medical device manufacturers. The task is daunting and very few busy manufacturers are regulatory mountain climbers. Reading the regulations provides only a small part of the picture. Understanding what the regulations mean and how compliance can be achieved in your environment is key. Graphic icons organize the text and provide a visual aid to definitions, regulations, procedures, documents, records, and points to remember. Applicable chapters also end with a FDA Investigator Icon, which summarizes what the FDA investigator will expect to see during an investigation.
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Dino Eleftheropoulos
reviewed Mastering and Managing the FDA Maze: Medical Device Overview : A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration on March 12, 2018
Mastering and Managing the FDA Maze
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Medical technology creates all kinds of fascinating questions, one of which is, "Where, if at all, should we stop?" What's the difference between giving an amputee a prosthetic and making a cyborg? If I can genetically modify my fetus so it won't have Down Syndrome, why can't I also modify it so it is beautiful? Or, white? In this book, Carl Elliott proffers a possible criterion: we should draw a line at making people "well." Once they wish to be "better than well," we should stop.
I found this to be an excellent book for considering limits, but it is at least worth the read for its examples. My favorite: there are people that are so convinced they are actually Civil War amputees they have cut off their own limbs without anesthetic. They went to doctors, but all doctors refused to perform the amputation because the limbs were healthy. If you were the doctor, what would you have done?
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Add Mastering and Managing the FDA Maze: Medical Device Overview : A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration, There is a mountain of information on FDA regulation and compliance for medical device manufacturers. The task is daunting and very few busy manufacturers are regulatory mountain climbers. Reading the regulations provides only a small part of the picture., Mastering and Managing the FDA Maze: Medical Device Overview : A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration to the inventory that you are selling on WonderClubX
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Add Mastering and Managing the FDA Maze: Medical Device Overview : A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration, There is a mountain of information on FDA regulation and compliance for medical device manufacturers. The task is daunting and very few busy manufacturers are regulatory mountain climbers. Reading the regulations provides only a small part of the picture., Mastering and Managing the FDA Maze: Medical Device Overview : A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration to your collection on WonderClub |
