Category: Clinical Evaluation
So here’s is a tip related to the use of the NOT Boolean operator as part of your search strategy (tI wrote this from a medical device clinical evaluation/systematic review perspective, but in practice it applies to any search and any literature review).
IMDRF Final Documents – Clinical Evidence, Clinical Evaluation and Clinical Investigation
Observation 1 – This is the third installment of my series on medical device clinical evaluation. I suggest reading the first part at (http://www.medicaldevice.expert/) to have a better understanding of the concepts so the understanding of this part is easier). The Clinical Evaluation Report – CER is the document which contains the results of the […]
Related to my post yesterday about medical device clinical evaluation and EBP (Evidence-Based Practice), this recent book (published late last year) is already a classic about the need and how to use critical thinking applied to EBP (and it also applies generally to any need of critical thinking). Recommended reading!
This is the second installment of my series on medical device clinical evaluation. I suggest reading the first part (How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities – http://www.medicaldevice.expert/europe/european-commission/medical-device-regulation/how-to-perform-a-clinical-evaluation-of-medical-devices-part-1-overview-and-sample-of-activities/0 to have a better understanding of the concepts so the understanding of this part is easier). […]
Finally got my copy of this interesting book on grey literature, which has great impact on medical device regulatory compliance. One of the definitions of grey literature is: “Grey literature stands for manifold document types produced on all levels of government, academics, business and industry in print and electronic formats that are protected by intellectual […]
So after reviewing some concepts for a Clinical Evaluation training I gave this week, some people asked me about sources of literature on how to perform a clinical evaluation. I notice that a lot of people does not seem to not that a clinical evaluation is nothing more than a specific application of a systematic […]
Análise do impacto da avaliação clínica no registro sanitário de dispositivos médicos de alto risco. Conclusões:Considerando a amostra de indeferimentos de registro sanitário estudada, os achados sugerem uma heterogeneidade tanto na qualidade quanto no formato dos dados fornecidos em avaliações clínicas pelas empresas que submetem registros sanitários de dispositivos médicos, especialmente relacionado à natureza metodológica […]
Proposed update to Clinical Evaluation documents