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Med-Tech News

Control del Diseño de Equipos Medicos

medical device design control

¿Como se gestiona el diseño de productos medicos destinados a curar y ayudar a las personas en su dia a dia? Aqui damos algunos apuntes sobre como tener controladas las varias fases de la vida de un dispositivo medico, desde la idea hasta su puesta en mercado.

Medical device manufacturer

medical device manufacturer

MDD (Medical Device Directive) definition of Medical device manufacturer seems to be not clear about this fact. If you are considered a medical device manufacturer, you shall place your legal name and adress close to the symbol in the labelling of the product. But who is the actual manufacturer of a medical device product? See article here ..

Software as a medical device: safety integrity level

software as a medical device safety integrity level

Discover how Medical devices IEC-62304 is the med industry-specific adaptation of the larger IEC-61508 standard

ISO 15223-1:2021 Medical devices — Symbols to be used

iso 15223-1 medical devices symbols

DevOps in Healthcare as Medical devops

devops process in medical devices software development

IEC 62304 vs Medical DevOps: choosing the software development process model

medical equipment software development process models

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