# International Standards & Capabilities | Spinex IO INTERNATIONAL STANDARDS & CORPORATE CAPABILITIES # Trust, Quality, and Harmony in Health Technology. At SPINEX IO, we conduct our processes in the fields of quality management, information security, software development, and health technology in accordance with international standards, official authorizations and a secure technology development approach. [Review our standards ↓](https://spinex.io#yonetim-sistemleri) QUALITY INFORMATION SECURITY SOFTWARE PROCESSES HEALTH TECHNOLOGIES R&D MANAGEMENT SYSTEMS ## We place quality and safety at the heart of our processes. We conduct our quality management, information security, and software development processes using a systematic, traceable, and sustainable approach. 01 QUALITY MANAGEMENT ### ISO 9001 Quality Management System Quality-oriented, traceable, and continuously improved corporate processes. Process Management Traceability Continuous Improvement 02 INFORMATION SECURITY ### ISO/IEC 27001 Information Security Management System A systematic security approach based on the confidentiality, integrity, and accessibility of information. Data Privacy Information Security Access Control 03 SOFTWARE PROCESSES ### Automotive SPICE Level 2 Process competence for conducting software development processes in a planned, manageable, and traceable manner. Planned Development Process Competence Software Traceability SPINEX IO · MANAGEMENT SYSTEMS **A standards-based, traceable, and sustainable technology development approach.** OFFICIAL AUTHORIZATIONS ## A Strong Corporate Infrastructure in Health Technology. SPINEX IO conducts its operations in the fields of health technology, industry, and digital health with a technology infrastructure that supports its activities with relevant registration, authorization, and corporate processes. HEALTH TECHNOLOGIES ### Medical Device Sales Center Authorization Certificate INDUSTRIAL INFRASTRUCTURE ### Industrial Registration Certificate Corporate Industrial Registration HEALTH TECHNOLOGIES **SPINEX** **IO** CORPORATE COMPLIANCE ECOSYSTEM CORPORATE CAPACITY ### Capacity Report Corporate Capacity Infrastructure DIGITAL HEALTH ### USBS Registration and Licensing Remote Health Information System PRODUCT SUITABILITY ### CE Conformity Certificates Within the scope of related products and devices CORPORATE COMPLIANCE APPROACH Official authorizations and registration processes are evaluated according to the corporate activity areas; CE conformity certificates are evaluated according to the scope of conformity of the relevant products and devices. INFORMATION SECURITY ## Health data security begins with design. In digital health systems, we consider data security not just a technical layer, but as part of the entire process, from software design to access management. A SAFE DATA JOURNEY 01 DATA SOURCE ### User The starting point where health data is generated or uploaded to the system. *›* 02 PROTECTED COMMUNICATION ### Secure Transfer Data is transferred between system components using a secure communication approach. *›* 03 DIGITAL PLATFORM ### System Data processing within the relevant software and digital health infrastructure. *›* 04 ACCESS MANAGEMENT ### Authorization Data access should be managed according to user roles and permissions. *›* 05 DATA MANAGEMENT ### Data Infrastructure Managing health data within controlled digital infrastructures. OUR SECURITY APPROACH **Five core areas** ✓ 01 **GDPR Compliance Processes** ✓ 02 **Secure Software Development** ✓ 03 **Secure Cloud Infrastructure** ✓ 04 **Data Privacy** ✓ 05 **Authorization & Access Control** SAFETY-FOCUSED DESIGN **Data security is addressed throughout all stages of the process: design, development, transmission, access, and data management.** CORPORATE COMPETENCIES ## A robust technological infrastructure spanning from R&D to product development. SPINEX IO combines an R&D-focused technology development approach with its expertise in supported projects, the technopark ecosystem, and health technology. TECHNOLOGY ENTREPRENEURSHIP ### Tech Entrepreneurship Badge A structure that supports our corporate position in the technology and innovation-focused entrepreneurship ecosystem. RESEARCH & DEVELOPMENT ### TÜBİTAK-supported R&D Projects A development approach that supports technology development and innovation efforts through R&D projects. SPINEX IO **R&D &** **TECHNOLOGY** INSTITUTIONAL COMPETENCE PRODUCT DEVELOPMENT & GROWTH ### KOSGEB Supported Projects Project experience supporting technology development, product development, and corporate capacity-building processes. TECHNOPARK ECOSYSTEM ### METU Technopark Ecosystem Technology development and R&D activities are carried out within an innovative technopark ecosystem. DIGITAL HEALTH ### Health Technology Specialization Digital health, wearable technology, medical IoT and technological expertise that brings together health software. SPINEX IO R&D PRODUCT DEVELOPMENT DIGITAL HEALTH MEDICAL IoT SOFTWARE SPINEX IO · QUALITY & TRUST ## Reliable technology begins with sustainable processes. For your digital health, medical IoT, and software projects, we develop customized solutions for your organization with our approach to quality, information security, and technology development. [Get in Touch →](https://spinex.io/en/page/cms/019ff5865178722782920f271a6ddf0a) SPINEX IO **QUALITY** **& TRUST** QUALITY INFORMATION SECURITY R&D HEALTH TECHNOLOGIES INTERNATIONAL STANDARDS INFORMATION SECURITY OFFICIAL AUTHORIZATIONS R&D & TECHNOLOGY