PubMed

Post-market surveillance of medical devices: A review.

PMID : 35964220 · 2022

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RevueTechnology and health care : official journal of the European Society for Engineering and Medicine

Année2022

PMID35964220

Résumé

Medical devices (MDs) represent the backbone of the modern healthcare system. Considering their importance in daily medical practice, the process of manufacturing, marketing and usage has to be regulated at all levels. Harmonized evidence-based conformity assessment of MDs during PMS relying on traceability of medical device measurements can contribute to higher reliability of MD performance and consequently to higher reliability of diagnosis and treatments. This paper discusses issues within MD

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