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CLINICAL EVALUATION OF THE DEGREE
OF TOLERANCE TO THE PHYSICAL EFFORT (ERGOMETER×TREADMILL)
If there is no doubt that you have a coronary artery disease or if there has already been
diagnosed, with
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Start by carefully reading the form instructions, ensuring you understand the purpose and requirements of the evaluation.
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Provide the medical history of the patient, detailing any pre-existing conditions, previous treatments, and medications they are currently taking.
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If applicable, include the results of any laboratory tests, imaging scans, or other diagnostic procedures conducted during the evaluation.
07
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Finally, include any additional notes or observations regarding the patient's response to treatment or any follow-up plans.
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What is clinical evaluation of form?
Clinical evaluation of form is a documentation that assesses the safety and performance of a medical device.
Who is required to file clinical evaluation of form?
Manufacturers of medical devices are required to file clinical evaluation of form.
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Clinical evaluation of form can be filled out by providing comprehensive data on the medical device's clinical performance and safety.
What is the purpose of clinical evaluation of form?
The purpose of clinical evaluation of form is to demonstrate that the medical device meets regulatory requirements and is safe for use.
What information must be reported on clinical evaluation of form?
The clinical evaluation of form must include data on the medical device's design, intended use, clinical data, risk analysis, and post-market surveillance.
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