Tag: Clinical Evaluation

How to perform a clinical evaluation of medical devices – Part 3 – Suggested Table of Contents for the Clinical Evaluation Report – CER

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 […]

How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means

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). […]

Grey literature and medical devices

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 […]

How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities

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 (Portuguese only)

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 […]