Post-marketing surveillance: why medical device safety doesn’t end with certification

10.12.2025

Quality management // № 12, December 2025

Market leaders have long viewed post-marketing surveillance not as a costly obligation, but as an investment in their own future. There are examples in the history of medical technology when critical flaws were later discovered in the latest developments that received certification. Mass product recalls, lawsuits, destroyed consumer trust – all this cost companies much more than the development of a timely and transparent monitoring system.

The text of the article is available only in Ukrainian

Other news

16.04.2024

Quality management system at enterprises designing, developing, producing and selling medical products. General information.

Read more
15.11.2024

Risk management, the basis of integrated management

Read more
30.09.2024

Conducting internal audits in accordance with the provisions of DSTU ISO 19011:2019

Read more