Please enable JavaScript.
Coggle requires JavaScript to display documents.
Ensuring compliance with regulatory standards in biomedical equipment…
Ensuring compliance with regulatory standards in biomedical equipment maintenance.
in colombia
some of them
are
their compliance must be presented in documents
health registration system,
calibration in sanitary control
legal metrological control
Decree 1595 de 2015.
decree 4725 de 2005
marketing permit
health surveillance of medical devices for human use.
stage in which Invima guarantees the control and monitoring of products along the production chain
RESOLUTION 4816 OF 2008 technovigilance
1 more item...
Resolution 434 of 2001 "Establishing standards for the evaluation and import of biomedical technologies
Decree 4725 de 2005, as amended by Decree 582 de 2017
verify compliance with the technical-legal and sanitary requirements established in Decree 4725 of 2005
Decree 4725 of 2005:
standards and resolutions are required for biomedical equipment,
