Medical device clinical literature review

On The Agenda
From: Andrey K.
Category: where coalition
Added: 01.04.2021
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No one knows your products and their use history better than you and your team. This is why we so often tell clients that have the staff to write their own CERs. In our experience, the CER is not the problem. Save your CER Writer time with our approach.
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EU MDR Clinical Evaluation Requirements – Understanding the CER

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Introduction - Literature Reviews - GSU Library Research Guides at Georgia State University

We are glad you asked! What is state of the art? Although state of the art is commonly defined as the newest idea or newest feature, state of the art in relation to European Commission regulations for medical devices does not imply the most technologically advanced solution. A guide for manufacturers and notified bodies" gives a definition of state of the art as:. It is important to note that the state of the art embodies what is currently and generally accepted as good practice in technology and medicine.
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Literature Reviews: Introduction

Answer individual questions by using collective scientific knowledge. Systematic literature reviews are common instruments to assess intervention effects of new medical procedures, devices or drugs and to estimate relationships between various parameters e. It is essential for the clinical evaluation of medical devices and as a result of the increasing proliferation of low-quality studies keyword: predatory journals , indispensable for any research project. Main pillars are keyword-driven search strategies defined in advance i.
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A well-researched Clinical Evaluation Report assures regulators such as notified Bodies, competent authorities, patients, and clinicians alike the confidence that medical device have been validated by strictly following guidelines, thus ensuring that their potential benefits outweigh any possible risks associated with their use. Complete clinical evidence collected during the clinical evaluation process is to be documented in CER and it shall be a part of the technical documentation which will support the assessment of the conformity of the device. As per this guidance, the CER should contain enough information to be read and understood by an independent party such as a regulatory authority or notified body. Thus, it should provide enough detail for understanding the search criteria adopted by the evaluators, data that are available, all assumptions made, and all conclusions reached.
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