Module 14: Design Development and Certification of Medical Devices

17/11/2023

Clinical Evidence

Clinical investigations are carried out to: • Establish/Verify performance of the device under normal conditions of use • Establish/Verify the benefits of the device as intended • Establish/Verify clinical safety and determine undesirable effects and whether they constitute acceptable risk when weighed against benefits And may be necessary to confirm clinical benefit/safety of any changes/modifications to the device

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

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• Review of clinical investigations • investigations reported in the literature on a device for which equivalence to the device can be demonstrated • Other supporting information (e.g. peer-reviewed scientific literature) • Other relevant information • such as data from a manufacturer’s post-market surveillance/clinical follow up Of sufficient quantity and quality to enable a qualified assessment of safety and achievement of intended clinical benefit Demonstrate a methodical and systematic evaluation of collecting, analysing and assessing clinical data, and continuing monitoring. CLINICAL EVALUATION REPORT

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

28

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