The clinical evaluation is an essential part of the technical documentation, which manufacturers are required to use to document their compliance with the general safety and performance requirements. The new medical Device Regulations places greater emphasis on the use of clinical data to demonstrate compliance with the general safety and performance requirements. And for certain... read more
This webinar was delivered live on 12th Oct 2017. The European Commission has recently published the new Medical Device Regulations which introduce new and more extensive requirements on manufacturers, Notified Bodies and other economic operators. Because of the scrutiny and re-designation requirements, we have already seen a significant decrease in the total number of Notified... read more
Since the late 1990s, FDA has expected Class II and III medical device manufacturers to apply human factors engineering (HFE) comprehensively to help reduce the chance of harm due to use errors. In 2016, FDA updated its HFE guidance to industry, specifying that submissions should include an HFE Report if the associated device requires users... read more
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