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See our compliance programs:

Hitachi Group Code of Conduct

COCIR Code of Conduct

Compliance

At Hitachi, we are fully committed to all our stakeholders – we strictly adhere to laws and regulations and act in an ethical and fair manner.

All our employees are required to fulfil all guidelines to act with sincerity and fairness in the healthcare business every day.

Quality

To generate value and trust amongst our customers, we design, run and control our processes to the highest standards.

We strive to continuously improve our business processes and are committed to operate a professional risk management system.

Download our certifications:

ISO 9001:2015 for Quality Management System

ISO 13485:2016 for Quality Management System for Medical Devices

We adhere to European legislations:

Medical Devices Directive (MDD)

Medical Device Regulation (MDR)

Regulatory

Diagnostic medical devices have to be safe and effective. This is influenced by many factors including hygiene, vigilance and governmental regulations.

We implement a streamlined regulatory strategy based on the Medical Devices Directive (MDD) and Medical Device Regulation (MDR) to ensure a professional and secure business environment in Europe.

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