اخبار و وقایع

Medical device landscape for communicable and noncommunicable diseases in low-income countries

Clinical Evaluation Report template in accordance with MEDDEV 2.7/1

SOP: Adverse Events in Medical Device Clinical Investigations

Risk management for medical devices

ISO 14971 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. ...

MEDICAL DEVICE CLINICAL TRIAL DESIGN, CONDUCT, AND ANALYSIS

The collection and evaluation of sound clinical data are the basis of the approval process for many medical devices. This paper outlines those topics that a sponsor must carefully consider in an effort to provide a meaningful evaluation and interpretation of clinical data in support of medical device Premarket Approval applications (PMA).

Clinical evaluation vs. Clinical investigation for medical devices

Many people colloquially refer to “clinical trials” as the source for clinical data for efficacy of treatments, where the trial is the activity of testing a medical device with patients to confirm that it provides clinical benefits. ...

دستورالعمل فعلی اخذ مجوز

انجام و ممیزی ارزیابی بالینی تجهیزات پزشکی اداره کل تجهیزات پزشکی

کانال تجهیزات پزشکی راه اندازی شد

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@MedDevClinical

https://t.me/meddevclinical

برگزار کارگاه Good Clinical Practice

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