TRCompany
Certificates, authorizations and R&D projects
Quality management system certificates, product and service authorizations, and the R&D and investment projects that have been completed or are under way.
Quality and management system certificates
| Certificate | Scope |
|---|---|
| ISO 9001:2015 | Quality management system |
| ISO/IEC 27001:2022 | Information security management system |
| ISO 45001 | Occupational health and safety management system |
| CE | GE-100 MultiSensor measurement and control unit |
| TSE service competence (TS 12426) | Technical service (Labor İldam) |
| Technical service authorizations | Laboratory equipment and oxygen monitor service |
| SME and enterprise class certificate | Micro/small enterprise, high technology level |
Contact us for originals and validity dates.
R&D and investment projects
| Project | Program | Period | Scope |
|---|---|---|---|
| 21 CFR Part 11 aligned biobank and GMP area measurement and control unit | KOSGEB product development | 2021–2022 | Development of the GE-100 MultiSensor; completed successfully, brought to market in 2023 |
| Cell and tissue biobanking and multi-vial tube scanning | KOSGEB R&D | 2023–2024 | The dynamic-process HDBO software and the camera-based GE-SCAN scanner; completed without revision |
| Establishment of a measurement and control unit production line | KOSGEB SME technology investment | 2026 | SMT placement line, reflow, conveyor and test infrastructure at Teknopark İstanbul |
| ISBT virtual laboratory sample tracking and equipment monitoring | Teknopark İstanbul project portfolio | 2021–2025 | Sample tracking and 21 CFR Part 11 aligned equipment monitoring |
| Cell and tissue banking manufacturing process software, phase 2 | Teknopark İstanbul project portfolio | 2024– | Second phase development of BIOSECURE HDBO |
| ŞAHİT secure sample and evidence tracking system | TÜBİTAK | 2026–2028 | Smart box, docking rack and chain of custody infrastructure (in R&D) |
Manufacturing infrastructure
The surface-mount line built at Teknopark İstanbul in 2026 comprises a placement machine, reflow oven, conveyor, soldering and test stations. Board design, firmware and manufacturing run under one roof, which is what makes variant production to field requirements and long-term spare part continuity possible.
See Roadmap and manufacturing for detail.