Our company successfully conducted a certification audit at LLC "Production Company PROSTIR" (Dnipro). According to the audit results, the company received certificates of compliance of management systems with international standards ISO 9001:2015 and ISO 13485:2016.
Who is "VK PROSTIR"
The company "VK PROSTIR" is a modern Ukrainian manufacturing enterprise specializing in the manufacture of tactical medicine and non-invasive medical devices. Among the key areas are the production of hemostatic tourniquets, soft stretchers and other products used in the field of medicine and defense.
The enterprise has a developed infrastructure, modern equipment and a team of over 130 highly qualified specialists. The company's products are already registered and recognized internationally, in particular, they have a NATO Stock Number, which allows them to be supplied to the Armed Forces of Ukraine and international partners.
The audit covered the company's quality management system in the following areas:
Production of hemostatic tourniquets, soft stretchers and other non-invasive medical devices.
During the audit, the compliance of processes with the requirements of ISO 9001 and ISO 13485 was assessed, including risk management, documentation, product design and development, supplier control, and mechanisms for continuous improvement.
ISO 9001:2015 is the most common quality management system standard in the world, confirming the stability of processes, customer orientation and the company's ability to provide high product quality.
ISO 13485:2016 is an international standard for manufacturers of medical devices, confirming compliance with safety requirements and regulatory standards in the field of healthcare, and also opens up opportunities to enter European and global markets.
Obtaining ISO 9001 and ISO 13485 certificates allows VK PROSTIR to:
-strengthen the trust of customers, partners and government customers;
-expand participation in international projects and tenders;
-increase competitiveness in domestic and foreign markets;
-guarantee the safety and quality of its products for end consumers;
-demonstrate the stability and reliability of production processes even in wartime.
We sincerely congratulate the VK PROSTIR team on this important achievement. The certification confirmed that the company not only meets high international standards, but also demonstrates resilience, innovation and readiness for further development.
We wish "VK PROSTIR" successful growth, new partnerships, and even wider recognition of Ukrainian products on the world stage.