Quality management // № 6, June 2026

In an era of intensive development of medical technologies, ensuring the quality and safety of medical products is becoming not just a competitive advantage, but a critical requirement for successful functioning in the global market.

The international standard ISO 13485 is a comprehensive quality management system developed specifically for the medical device industry, which helps organizations not only meet regulatory requirements, but also demonstrate their commitment to the highest standards of safety and effectiveness.

The implementation of this standard creates a solid foundation for the entire production process, from conceptual design to final disposal of products, ensuring the confidence of patients, healthcare professionals and regulatory authorities in the quality of products.

The text of the article is available only in Ukrainian