Ellen Neven

4 articles

Clinical22 jun 2023 1 min

State of the Art (SOTA) Literature Review – What, Why, When, and Who?

In this post, we share the definitions, time points, and resources required to execute a systematic State of the Art (SOTA) literature review as required.

Clinical18 jun 2023 1 min

Clinical Literature Review – Common Gaps and Hurdles to Take

In this blogpost, we are sharing our experience on the common gaps and hurdles that manufacturers are facing when undertaking this Systematic Literature Review (SOTA).

Regulatory Affairs5 abr 2022 11 min

Clinical Evaluation Report (CER): a must-have for all medical device classifications

To document the clinical evaluation of your device, a Clinical Evaluation Report or CER must be compiled. Learn more about this key document.

Regulatory Affairs5 abr 2022 3 min

Clinical Evaluation Plan (CEP): roadmap of the clinical evaluation strategy

The Clinical Evaluation Plan is a key guide for the clinical evaluation of your medical device. Learn more about the CEP and its requirements.

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