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At HCEU, Quality defines who we are. Our leadership team is committed to achieving exceptional business excellence while meeting the expectations of our stakeholders and adhering strictly to all regulatory and corporate governance standards.
Our workforce is the backbone of our performance. We rigorously design, control, and optimize our processes to consistently deliver superior value and build unwavering confidence with our clients.
Accountability for continuous improvement is embedded across all levels of our organization, driving sustainable growth and long-term success for HCEU and our partners.
We are dedicated to full compliance with all applicable regulatory, statutory, and customer requirements, ensuring the ongoing effectiveness and reliability of our Quality Management System.
Our parent company in Japan, the manufacturer, guarantees product conformity through its certified Quality Management System and the application of the CE mark. As the European Authorized Representative, FUJIFILM Healthcare Europe GmbH is fully integrated into FUJIFILM Corporation’s comprehensive quality framework, ensuring alignment and consistency across all operations.
Within Europe, Fujifilm Healthcare maintains its own robust and long-established Quality Management System, encompassing our European headquarters and affiliated entities. Our commitment to quality and compliance is demonstrated through certifications to the following international standards:
ISO 9001: General requirements for a quality management system
ISO 13485: Specific requirements for a quality management system for medical devices
ISO 27001: Requirements for an information security management system (ISMS)
This integrated approach ensures that quality, safety, and security remain at the forefront across all stages of product development and delivery throughout Europe.
Highlighting our commitment to quality through leadership, process excellence, and continuous improvement across every action.
Quality is not a static goal, but a perpetual journey; through a culture of continuous improvement, we rigorously enhance our processes, reduce defects, and deliver increasing value to our customers, striving for excellence in every action.
Quality Manager, Fujifilm Healthcare Europe
FUJIFILM Healthcare Europe GmbH serves as the authorised representative (EU REP) for Fujifilm medical device manufacturers based outside the European Union. In this capacity, we are registered in the European database EUDAMED and undertake key responsibilities under the European Medical Device Regulation (MDR). These responsibilities include managing essential technical documentation and acting as the primary liaison with regulatory authorities throughout Europe.
All Fujifilm products fully comply with the latest European regulations, directives, and standards. Our medical devices are designed not only to meet stringent technical performance criteria but also to ensure hygienic standards that are essential for clinical environments.
For your convenience, we provide access to three essential resources linking to relevant databases and documents:
To support you in the safe and effective use of our medical devices, we provide easy access to key resources, including user manuals, hygiene guidelines, and safety data sheets. Whether you need detailed instructions, cleaning protocols, or product safety information, these tools are designed to help you maintain the highest standards of care and compliance.
Access the user manual for your device in your preferred language through our Medical Documents Library. Please note, some product groups require a username and password provided with the product for access.
Presenting regulatory leadership in a clear and structured format that reflects trust, responsibility, and continuous process improvement.
Effective regulatory compliance requires moving beyond a “check-the-box”mentality to embed a culture of continuous improvement, where organizations proactively analyze data, assess risks, and refine processes to not only meet current standards but to exceed evolving safety and quality expectations.
Quality & Regulatory Manager, Fujifilm Healthcare Europe
To support you in the safe and effective use of our medical devices, we provide easy access to key resources, including user manuals, hygiene guidelines, and safety data sheets. Whether you need detailed instructions, cleaning protocols, or product safety information, these tools are designed to help you maintain the highest standards of care and compliance.
