INVIMA: Inauguration of the new quality control laboratory for medical devices
NEW LABORATORY OF MEDICAL DEVICES WILL INCREASE AT 74% ANALYZED UNITS
National Accreditation Agency of Colombia (ONAC) granted accreditation to 21 methodologies under ISO / IEC 17025: 2005
The National Institute for Food and Drug Surveillance (INVIMA) today inaugurated the new facilities of its laboratory for quality control of medical devices, which will allow the institution to analyze more than 18 thousand samples a year, an increase of 74 percent in relation to previous years.
This modern laboratory went from 33 m2 to 88 m2, which meant increasing its capacity to perform analyzes on medical devices such as: condoms, syringes, gloves, sutures, peripheral intravenous catheters, macrogoteo equipment, among others.
On the other hand, the National Accreditation Agency of Colombia (ONAC) granted accreditation to 21 methodologies under ISO / IEC 17025: 2005, in reference to latex male condom tests, sterile latex gloves, syringes and hypodermic needles
“As a health agency in the country we are proud to have an accredited laboratory, a pioneer in the Americas region in conducting quality control tests for Medical Devices and generators of research and innovation for the technical-scientific development that you need Colombia, “said Guzmán Cruz.
He also added that with the strengthening of human talent, infrastructure and acquisition of new equipment in 2018, the Medical Physical Devices Laboratory, will apply new technologies designed to meet the quality specifications of medical devices and will maintain the risk approach to evaluate the products with the greatest impact on the health of Colombians.
The challenge continues in the implementation of increasingly demanding projects, which position laboratories as a fundamental axis in the framework of the responsibility of health surveillance and in the issue of quality control, safety and efficiency of medical devices.