Quality Policy Statement:
Flash Pathology specializes in the development of microscopy systems for imaging cell and tissue samples.
While the primary target application is in histopathology for oncology research and diagnostics, the system is also appropriate for a range of clinical applications where biopsy samples are crucial for differential diagnostics and procedure efficacy evaluation, such as inflammatory diseases, autoimmune disorders, and transplantation medicine.
Our commitment at Flash Pathology is to support healthcare by providing reliable diagnostic tools, thereby improving patient outcomes. This Quality Policy below guides our team, ensuring that we consistently achieve and uphold the highest standards in product development and service delivery.
· Patient Focus: Our priority is to meet the needs of patients and our healthcare partners, ensuring our products deliver reliable, accurate, and effective results.
· Regulatory and Statutory Compliance: Flash Pathology is committed to consistently meeting the requirements of ISO 13485, IVDR, and other pertinent regulatory and statutory standards. We have established and maintain a robust quality management system to ensure its continued effectiveness.
· Continuous Improvement: We acknowledge the evolving nature of the medical field.
To this end, we are committed to the continuous enhancement of our products, services, and our quality management system.
· Risk Management: Risk assessment and mitigation are integral to our processes.
Our foremost concern is patient safety, and we make concerted efforts to manage risks associated with our products throughout their lifecycle.
· Employee Development: Our team's competence is vital.
We prioritize regular training and professional development to ensure our team is well-versed with current standards and practices. Every member understands their role in upholding the quality and safety of our products.
· Collaboration & Feedback: We maintain open channels of communication with healthcare professionals, regulatory bodies, and other stakeholders.
Their feedback is vital in refining our products and processes.
· Ethical Conduct: At Flash Pathology, we adhere to the highest ethical standards, ensuring the protection of patient data and respecting individual rights.
Flash Pathology B.V.
De Boelelaan 1085
1081 HV Amsterdam
The Netherlands
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At Flash Pathology, we are committed to empowering you with advanced tools to visualize and understand the intricate details of tissue samples.
All products and application data are intended for research use only and are not approved for diagnostic or therapeutic purposes.