R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

When Benefit Outweighs Risk: Creating a Successful Clinical Evaluation Report - A Case Study

About R&Q's Case Studies: We hope you enjoy our third case study. View all of our available Case Studies. Subscribing to our blog is the best way to know when future case studies are available.

 

Challenge

High volume of data... and differing opinions.

A client's product is utilized on critically ill patients in intensive care units. As a result, comorbidities and adverse events during the use of the device are inevitable. There were more than a thousand customer complaints and hundreds of serious adverse events reported to public databases for the subject device and comparative devices. Notified body findings on the previous clinical evaluation reports and internal conflict over the requirements added to the confusion.

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