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What is a Clinical Evaluation Report (CER)?
A Clinical Evaluation Report (CER) is a detailed summary of the evaluation of information pertaining to clinical...
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Quality System Remediation and Root Cause Analysis
Successful quality system remediation relies on understanding why problems arose, generally referred to as “root cause analysis.” ...
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Clinical Evaluation Report (CER) Literature Searching
To maintain compliance with heightened requirements under the Medical Device Directive (i.e., recent Notified Body implementation of...
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Regulatory research on IDE exemptions: A case study in persistence (part 2)
In our previous blog post, we described our preliminary regulatory research study on whether our client’s electronic...
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