Sakura Finetek Japan Co., Ltd.
Sakura Finetek, a leader in pathology lab equipment since 1947, automated lab documentation and device certification with PaperOffice AI for complete traceability.
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The Situation
Sakura Finetek develops and manufactures lab equipment for pathology diagnostics, used in hospitals and labs worldwide. Each device requires extensive certification documentation.
Regulatory requirements in medical devices are extremely strict. FDA, CE, PMDA, and other authorities demand complete documentation for every single product.
Pathology lab data must be retained for decades and be traceable at any time – a requirement that was difficult to meet with paper-based documentation.
Pathology lab documentation and device certifications must be absolutely error
Challenge & Solution
Challenges
- Strict regulatory requirements (FDA, CE, PMDA)
- Extensive certification documentation per device
- Long-term archiving of lab data over decades
- Multi-market compliance for global distribution
- Paper-based processes in a traditional Japanese company
Solutions with PaperOffice
- Automated certification management for FDA, CE, and PMDA
- AI-supported document classification for lab data
- Tamper-proof long-term archiving with complete audit trail
- Automatic assignment of documents to device sub-assemblies
- Multi-market dashboard for certification status worldwide
The Implementation Process
Measurable Results
Before vs. After
Pathology lab documentation and device certifications now run fully automatically. Complete traceability for every specimen.
Why PaperOffice?
Compliance in medical technology
Discover how PaperOffice revolutionizes documentation in regulated industries.