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jb678 replied to the topic Risk Management Selection in the forum Project Management Process and Medical Device Development 6 years, 3 months ago
I would have to say that the pros and cons of a single, or separate team would vary dependent upon the project. If it were a small project with low risk then there would be more pros in the favor of a single team that handles both project, and risk management. Class I devices are a good example of a project that would only require one team, as they are simple devices with a very low risk. However if there was a much larger project, such as a class III device, a separate team should be made to handle the risks of the device. Class III devices have much more of a risk, as many are invasive, or requiring vigorous testing. Having a separate team may require more time before production/experimentation can begin, but it will ensure that the device is much safer. A separate team allows for a more dedicated investigation, and brings more perspective into what could go wrong.