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Study title: A Clinical Evaluation of the Safety of ER Capsules (GRS) When Administered Once Daily to Subjects with Spasticity due to Multiple Sclerosis (MS): An Open Label, Long Term, Safety Trial
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What is a clinical evaluation of?
A clinical evaluation is an assessment of the safety and performance of a medical device.
Who is required to file a clinical evaluation of?
Manufacturers of medical devices are required to file a clinical evaluation.
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A clinical evaluation should be filled out by gathering and analyzing clinical data related to the medical device.
What is the purpose of a clinical evaluation of?
The purpose of a clinical evaluation is to demonstrate the safety and performance of a medical device.
What information must be reported on a clinical evaluation of?
A clinical evaluation must report on clinical data, risk management, and any changes or updates to the device.
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