Quality management of medical devices: we apply ISO 13485:2016 without errors

01.05.2021

Quality management // № 4 (40), April 2021

The text of the article is available only in Ukrainian

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26.08.2021

Medical devices in the nomenclature of pharmaceutical manufacturers. Conformity assessment of in-vitro diagnostic medical devices

PROGRAM Devices at the border of definitions: medical devices supplied with the medicinal product; medical devices as a means of drug delivery; devices, an integral part of which is a medicinal product; devices for IVD, RUO (research use only) and general laboratory equipment. Conformity assessment through self-declaration. Conformity assessment performed by conformity assessment body: choosing […]

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23.01.2020

Guidelines for medical devices

The Ministry of Health of Ukraine approved guidelines that are developed on the basis of relevant documents of the European Commission (MEDDEV) for an unambiguous interpretation of technical regulations regarding medical devices, medical devices for in vitro diagnostics and active implantable medical devices. The recommendations are not legally binding, but should be taken into account […]

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12.10.2023

Recognition of CE Certificates for Medical Devices in 2023: What You Need to Know?

The American Chamber of Commerce in Ukraine, jointly with the member company UNI-CERT LLC, is glad to invite you to the upcoming Knowledge Webinar “Recognition of CE Certificates for Medical Devices in 2023: What You Need to Know?” scheduled for Tuesday, October 17, 11:00 AM. Don’t miss an exceptional opportunity to learn from speakers on the main principles of […]

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