Stand-alone software as a medical device: Features of its classification and conformity assessment

24.09.2020

Journal “Standardization, certification, quality” № 4 (122)/2020

Over the past decades, the frequency of using software in various areas of human life has increased significantly. In particular, this product has taken an important place in the medical industry. For example, as an integral part of a medical device (software incorporated in medical devices or pacemaker firmware), or as standalone software. One of the key questions that has medical software manufacturers before they put into service their devices is: the software really qualifies as a medical device or not. After all, not all software used in the medical field can be qualified as a medical device. In view of this, the purpose of this publication is to study the factors that can influence on the classification of stand-alone software and assessment of its conformity.

The text of the article is available only in Ukrainian

Other news

12.04.2021

Certification of medical devices during a pandemic. Remote audits, recognition of conformity assessment results, held outside Ukraine

The Ukrainian Scientific Institute of Certification invites you to take part in the 10th anniversary Ukrainian forum of medical device market operators, within the framework of which our specialists will make a report on the topic: “Certification of medical devices during a pandemic: remote audits, recognition of the results of conformity assessment carried out outside […]

Read more
28.02.2019

Legalization of import products for the Ukrainian market of medical products

After the events of 2014, Ukraine took the path of development, oriented towards the European Union. On September 1st, 2017, the Association Agreement between Ukraine and the EU entered into force. Ukraine assumed the responsibility to follow the path of harmonization with EU legislation and, as a result, some changes took place in the regulatory […]

Read more
08.06.2022

UNI-CERT received accreditation for DSTU EN ISO 22716:2015

The Ukrainian Scientific Institute of Certification became the FIRST conformity assessment body in Ukraine, accredited to carry out activities in a new line of business: DSTU EN ISO 22716:2015 Cosmetics. Good Manufacturing Practice (GMP). Guidelines on Good Manufacturing Practices (EN ISO 22716:2007, IDT) and EN ISO 22716:2007 Cosmetics – Good Manufacturing Practices (GMP) – Guidelines […]

Read more