As a developer and manufacturer of medical devices, all products are developed according to the ISO 13485:2003 standards, and designed to meet the FDA & CE Regulations.
Our design center and manufacturing lines are monitored by the standard organizations on annual based
Over the last 14 years, dozens of products have been developed according to well defined design control and documentation as required by the different regulatory agencies.
All the engineering and manufacturing is managed by a sofisticated software developed internally over the last ten years, handling the product life cycle, from design to manufacturing.