Quality With ISO Standards

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

Screentec Oy has defined the main, management, and support processes covered by its quality management system. These processes have been documented, with clear descriptions of their owners, inputs, and outputs. The main processes begin with sales and marketing, continue through design and productionization services, and culminate in the delivery of finished products to customers. The support processes ensure the reliability and continuous development of production by maintaining equipment, managing resources, and providing ongoing personnel training. The management processes are responsible for planning, steering, and analyzing operations to improve the quality management system (QMS) and ensure compliance with relevant regulatory requirements.

Screentec Oy increasingly manufactures medical devices, point-of-care diagnostic devices, and their components for its customers. We are committed to expanding our market share among clients requiring ISO 13485 and ISO 9001 -compliant suppliers, aiming to make medical device contract manufacturing our largest and most profitable product segment.

The certification process was conducted by Kiwa Sertifiointi Oy.

You can download our ISO 13485 Certificate HERE.
You can download our ISO 9001 Certificate HERE.