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Teamer

South Korea

Teamer ALM -Integrated solutions for requirements and development management based on international standards -Support for IEC 62304, ISO 14971, ISO 9001, and ISO 13485 -Support for Automotive SPICE, ISO 26262, and ISO/SAE 21434 eQMS -nternational Medical Device Quality Management System Stand...

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VWAY

South Korea

VWAY is a software development company that values the safety and security of the healthcare industry, offering 3P-based (Product Technology, Process Consulting, and People Training) all-in-one services. First, VWAY supports PEMS-based lifecycle processes and software engineering technology consulting in line with the trends in IoT healthcare medical services. It provides international standard licensing and quality process consulting for medical devices, such as ISO 13485, IEC 62304, ISO 14971, and CMMI, along with consulting for compliance with cybersecurity standards. Second, VWAY offers its own software solutions: Teamer, VisualPro, RAS, and SBOM. Teamer is a requirement tracking and management solution, an eQMS that manages the software development lifecycle. In particular, standard processes such as IEC 62304, ISO 13485, and ISO 14971 are applied to provide a variety of functions (requirements tracking management, issue management, output creation, review, and approval) to help customers manage the overall development process. VisualPro is based on ISO 14971, an international standard for risk management of medical devices, and provides FMEA analysis functionality to systematically identify and manage the likelihood and risk of failure of medical devices. RAS is an AI-based solution for development requirement quality verification, which enables the derivation of optimal requirements based on the rules of the international standard INCOSE during the requirements writing phase. SBOM (Software Bill of Materials) is essential for managing software components due to increasing cybersecurity threats and the expanding use of open-source software. Teamer SBOM provides efficient functionality for creating SBOM, analyzing dependencies, conducting NVD security vulnerability analysis, and managing vulnerability resolutions. Third, VWAY provides training for international certification and expert development in fields such as software safety and cybersecurity. It supports expert training through various courses, including software safety expert qualifications and AI safety expert qualifications.

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