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jb678 replied to the topic It's the Right Thing To Do in the forum Project Management Process and Medical Device Development 6 years, 2 months ago
manolo the issue with what you are asking is that ISO are regulations that must be required. Different devices need these regulations or else they will run into issues with the FDA. The FDA could then stop these companies from selling the product. If for example Philips made an electric toothbrush that needed to have insulation regulations checked, but decides to skip these regulation tests the product could be taken off the shelves of a store due to its possibility of shocking someone. This week we did a mini-sim where you were given an option to skip weeks 8 and 16 of animal testing. Cutting corners is wrong, especially for a billion dollar company like philips. Sure they may save money by cutting down on resources such as “man-power”,etc. However, when the FDA catches on it will come back to bite the company in the butt as they will have to recall their unregulated device. Which would mean all the research, and time they saved would have gone to waste due to the product not even being able to be sold, and customers returning it due to its recall. In the end cutting corners may be effective, but it definitely is not worth it; especially with medical devices.