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devicefordummy
I work in the clinicl research depart of our company and would like to understand regulations pertainning to sponsor rather than manufactuer. I have a few questions and hopefully someone can help clarify!!
1)Does Reportable Event apply to non-significant device studies only? What are the criterias?
Does AE in device studies apply to Significant studies only?
2) Do MDRs apply to Significant studies only? I was advised by my company's regulatory that reportable events are submitted on MDRs and adverse events are submitted by the company's own AE template. Is this correct?
1)Does Reportable Event apply to non-significant device studies only? What are the criterias?
Does AE in device studies apply to Significant studies only?
2) Do MDRs apply to Significant studies only? I was advised by my company's regulatory that reportable events are submitted on MDRs and adverse events are submitted by the company's own AE template. Is this correct?
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