Engineering Services

Irmato has following ISO-certifications:

• ISO 9001: The ISO 9001 is the international standard for quality management systems. In this way Irmato meets the requirements set for a structured way of quality management. Irmato establishes, documents, implements, and maintains a quality management system and continually improves its effectiveness in accordance with the requirements of the ISO 9001.

• ISO 13485: This ISO standard represents the requirements for a comprehensive management system for the design and manufacture of medical devices. ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements applicable to medical devices and related services. Irmato meets the requirements of ISO 13485 and is licensed supplier of medical devices.