Risk management for medical devices and the new standard DSTU EN ISO 14971:2022

Other news

24.09.2020

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

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 […]

24.01.2022

Cosmetic product safety: production regulation

Quality management // № 1-2 (49-50), January 2022 Guaranteeing the safety of products for consumers is a very important component of the image of cosmetics manufacturers. The leading motivation for the transition to work on GMP will be the standardization of production processes and the implementation of measures that make it possible to produce high-quality, […]

10.12.2019

Recognition of EU certificates for medical devices in Ukraine. Simplification, shortening of term and reduction of costs for conformity assessment with the requirements of Technical Regulations.

Since the Technical Regulations entered into force, discussions on the possibility of simplifying conformity assessment procedures, especially for medical devices of high-risk classes have been underway. Recently, we have had positive and relevant news regarding the recognition procedures in Ukraine for certificates of conformity issued by some notified bodies, accredited in the EU. To put […]