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

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

Clinical Medical Devices

Jun 22, 2023 10:00:00 AM

State of the Art (SOTA) literature review is part of the clinical evaluation process of a medical de...

Blog - Clinical Literature Review - Common gaps and hurdles to take - QbD Group

Clinical Literature Review – Common Gaps and Hurdles to Take

Clinical Medical Devices

Jun 18, 2023 9:00:00 AM

To get and maintain market approval in the EU (CE marking under MDR), state-of-the-art (SOTA) litera...

Clinical Evaluation Report: must-have for all medical device classifications - QbD Group

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

Regulatory Affairs Clinical Medical Devices

Apr 6, 2022 1:00:00 AM

Clinical evaluation of a medical device – defined as an ongoing collection, generation, appraisal, a...

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

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

Regulatory Affairs Clinical Medical Devices In Vitro Diagnostics

Apr 6, 2022 12:00:00 AM

Clinical evaluation of a medical device is central to obtaining and maintain ing market approval in ...