An introductory guide to medical device Clinical Evaluation & Clinical Evaluation Reports (CER) скачать в хорошем качестве

An introductory guide to medical device Clinical Evaluation & Clinical Evaluation Reports (CER)

This webinar provides a detailed exploration of medical device Clinical Evaluation under the EU MDR, along with an in-depth look at requirements for Clinical Evaluation Plans (CEPs) and Reports (CERs). The video aims to help you navigate through the Clinical Evaluation process and successfully write your own CERs and CEPs. STOP PRESS: We are now offering a FREE CEP for qualifying companies - but it's limited to 2 per week. Follow the link below to apply: www.mantrasystems.com/free-cep Learn how to structure and design your Clinical Evaluation Report (CER) using our FREE CER template: https://www.mantrasystems.com/enable-... Use our free guide to gain a further understanding of Clinical Evaluation: https://www.mantrasystems.com/eu-mdr-... The webinar includes: 1. What is Clinical Evaluation? Clinical Evaluation is described as a systematic and planned process to continuously generate, collect, analyse and assess the clinical data of a medical device in order to verify safety and performance, including clinical benefits. The first section of the video unpacks what this means in practice. 2. About Systematic Literature Reviews Good quality literature reviews sit at the heart of all successful Clinical Evaluations. A minimum of two need to be conducted - one in relation to the SOTA, and one for the subject device itself. Each review requires definition of an overall purpose, which should be set out on paper and used to guide construction of research questions and search terms. Once the overall purpose has been defined, the next step is to develop a search protocol which guides identification, appraisal and analysis of sources during the review. Next, you need to begin crafting research questions which are fed by the overall purpose followed by search terms to address the research questions. Extractions, screening, appraisal and analysis is then conducted. 3. Basic considerations when writing a Clinical Evaluation Report: Is the product in question a medical device? What risk classification does the device fall into? Understand the relevant GSPRs (General Safety & Performance Requirements) by interpreting Annex I of the MDR. Understand competitor safety & performance to establish safety and performance objectives Analyse all data on subject device safety & performance to assess levels of conformity, whether it is suitable for intended purpose, benefit-risk profile and performance vs benchmarks. Conclusions 4. An overview of Clinical Evaluation Report (CER) sections: Administrative particulars Executive summary Scope of the Clinical Evaluation Summary of Clinical Evaluation Plan (CEP) Harmonised standards Clinical Evidence review (SOTA) Equivalence (optional) Clinical Evidence review (subject device) Discussion of conformity with GSPRs and alignment with S&P objectives Analysis of benefit risk-profile Conclusion 5. Important information required for new devices You will need a clear idea of the device's intended purpose. Before completing the Clinical Evaluation it is important to make sure the stated intended purpose is harmonised across the full breadth of the device's technical documentation. 6. Question & Answers --------------------------------------------------------------------- Mantra Systems offers a full Clinical Evaluation service for all classes of medical device with 100% Guaranteed Notified Body acceptance: https://www.mantrasystems.co.uk/medic... Be sure to check out our article on how to choose a CER writer for your MDR Clinical Evaluations too:- https://www.mantrasystems.co.uk/artic... Please like and share the video to help our channel to grow. Also, please leave a comment - let us know your medical device regulatory challenges and we will try and answer as many questions as we can. Music by www.bensound.com #clinicalevaluation #clinicalevaluationreport #clinicalevaluationplan #cers #medicalwriting #systematicliteraturereview #regulatorycompliance #medicaldevice