While the info about the MedDev class is not given, recall that not every type of device can injure the Pt, and the measures are variable depending on how and if a device could cause injury. Also NB that the regs only refer to the device causing injury. Also recall that this is within the device 'intended use' and 'reasonable, foreseeable mis-use'. Now it is realized that a Pt can still complain/file suit, but one should not panic that it will move forward without just cause.
Agree that some external review is needed, perhaps legal a/o financial, etc., but insurance is not the only mitigation. For example, some companies are self-insured, or even have a bond reserved for such cases. It depends on several factors. Hope this helps.
Agree that some external review is needed, perhaps legal a/o financial, etc., but insurance is not the only mitigation. For example, some companies are self-insured, or even have a bond reserved for such cases. It depends on several factors. Hope this helps.