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The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study
The European Union Medical Device Regulations 2017/745 entered into force on May 2021 with changes related to strengthening the clinical evaluation requirements, particularly for high-risk devices. This study investigates how the increased requirements on medical device manufacturers in relation to...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Springer International Publishing
2023
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10276779/ https://www.ncbi.nlm.nih.gov/pubmed/37198369 http://dx.doi.org/10.1007/s43441-023-00527-z |