Year: 2024
Type: article
Abstract: Establishing the state-of-the-art (SOTA) represents a crucial aspect of a clinical evaluation under the European Medical Device Regulation (EU MDR) 2017/745. In this article, I share my experience of working on SOTA documents over the last four years. It first briefly recapitulates the SOTA requirements of the EU MDR (that are in fact almost non-existent) followed by the different steps required to conduct and document the literature search. Also included are some tips and tricks on structuring the SOTA. Finally, advantages and limitations of different scientific literature databases are provided.
Source: Medical Writing
DOI: 10.56012/voji4962
Author: Clotilde Jumelle
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4406238419