Quality with ISO standards

Our ISO 13485 and certification supports our growth as a contact manufacturer of medical devices and components.

We have certified our Quality Management system for the contract manufacture of medical devices and their components in accordance with ISO 13485 standards. The standards focus on improving our risk management capabilities as well as developing our company operations. The certification process was handled by Kiwa Inspecta Sertifiointi Oy.

Screentec Oy is increasingly involved in the process of productization and manufacture of medical devices and their components for our customers. Our goal is to increase our market share in the segment of customers that require their suppliers to operate in accordance with the ISO 13485 standards. Screentec Oy strives to make the contract manufacture of medical devices and their components it’s largest product category, both in terms of turnover and profit.

In December 2019, Screentec has received its ISO 9001 certificate as well, further expanding our quality management systems and allowing us to provide ever better service to our clients.

You can download our ISO 13485 Quality Certificate HERE.

You can download our ISO 9001 Quality Certificate HERE.

You can download our EU Declaration of conformity for Screentec Medical Face Mask (type II, non sterile), Scr MFM02_CE, 009051797 HERE