Device Medical Surveillance Technovigilance

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Medical device surveillance with electronic health records

https://www.nature.com/articles/s41746-019-0168-z

Device surveillance in the United States relies primarily on spontaneous reporting systems as a means to document adverse events reported by patients and …

TECHNOVIGILANCE AND RISK MANAGEMENT …

http://www.scielo.org.co/scielo.php?script=sci_arttext&pid=S1909-97622017000100008

At present, when it comes to technovigilance in clinical institutions, it is important not only to include a reactive approach (based on …

Market surveillance and vigilance - Public Health

https://health.ec.europa.eu/medical-devices-sector/directives/market-surveillance-and-vigilance_en

BRAZIL: ANVISA provides an online database for adverse events …

https://www.thema-med.com/en/2022/02/24/brazil-anvisa-provides-online-database-adverse-events/

BRAZIL: ANVISA provides an online database for adverse events. In order to reinforce the notification and monitoring system in health surveillance, after the online …

MINISTRY OF HEALTH - Global Medical Device Consulting

https://www.emergogroup.com/sites/default/files/mexico-nom-240-technovigilance-en-rev-0520.pdf

The purpose of Technovigilance is to guarantee that medical devices currently available on the market work as indicated in accordance with the manufacturer's intended use …

RESOLUTION – RDC N. 67, OF 21 DECEMBER, …

https://www.fda.gov/media/93179/download

causes a disability or permanent damage in a structure of the body; requires medical or surgical intervention to prevent permanent harm to a function or structure of the body; …

Health Surveillance of Medical Devices -Tecnovigilancia – El …

https://latinalliance.co/en/2023/02/06/health-surveillance-of-medical-devices-tecnovigilancia-el-salvador/

What is technovigilance? It is the regulatory function of post-market surveillance of medical devices that includes a series of activities aimed at the …

Technovigilance for Medical Devices in Mexico - Veraque Mexico

https://veraqueconsulting.com/mx/technovigilance-for-medical-devices-in-mexico/

A surveillance program is part of any entity or party related to the medical device. Even patients, nurses and physicians are encouraged to report an incident. Nevertheless, the …

NOM-240-SSA1-2012, Installation and operation of Technovigilance.

https://www.mexicanlaws.com/SALUD/NOM-240-SSA1-2012.htm

NOM-240-SSA1-2012, Installation and operation of Technovigilance. Published DOF Oct. 30, 2012 This Standard is under the oversight of the SSA = …