Escopo da BSI para o MDR – Regulation (EU) 2017/745 on medical devices http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.pdf&dir_id=34&ntf_id=288798
MHRA – Field safety notices – 03 to 07 December 2018. As a reminder, as part of Post Market Surveillance (PMS), manufacturers should track field safety notices to verify if similar devices had problems, and if the case, investigate if their device can also suffer from the same problem (and take action related to that). […]
