Quality Management

The DQS audit company has audited embeX and certified that embeX has introduced and is using a quality management system for the area of application “Engineering services for the development of embedded hardware, software and mechanical engineering for the control of technical devices to meet customer specific requirements" and for the core business of "engineering services for safety critical applications from conceptual design down to preparation for series production"”.

In the context of an extensive audit, embeX demonstrated that it has introduced and is using a functional safety management (FSM) system. embeX was the first company to be certified by TÜV Rheinland as having the highest possible maturity level 5 for the FSM system. The requirements of the IEC 61508 standard are the subject matter of this audit:

• Functional safety management (FSM)
• Documentation
• Assessment of functional safety
• Company specific safety lifecycle phases in accordance with the certified area of application: IEC 61508:2010 E/E/PE safety-related system deployment (Phase 10)

The DQS Medizinprodukte GmbH audit company has audited embeX and certified that embeX has introduced and is using a quality management system for the area of application, “services in the field of product and system development for embedded systems (hardware and software), from conception to support for series production in the field of medical technology”.