| CEO | Kyunghyun Roh | ||
|---|---|---|---|
| Address | (04559) 서울 중구 퇴계로 243 (충무로5가, 평광빌딩) | ||
| Tel | 02-508-3913 | Homepage | http://www.vway.co.kr |
| Exhibits |
Teamer is a solution equipped with features for managing medical device software development projects and application lifecycle management, based on international standard certification processes such as ISO 13485, IEC 62304, and cybersecurity. Teamer supports overall project management and monitoring. The powerful standard management features of this solution help medical device developers and regulatory affairs (RA) professionals improve document efficiency, comply with various medical device and healthcare regulatory requirements, and manage projects effectively. Additionally, Teamer supports software verification in accordance with ISO 13485, ISO 14971, and IEC 62304, enabling efficient certification management and quality control through continuous development quality assurance. These capabilities enhance the quality of the medical device development process, reduce the time required for certification, and alleviate compliance burdens. VisualPro supports comprehensive safety and security analyses such as FMEA, FTA, STPA, and TARA, as required by standards like A-SPICE, CMMI, DO-178C, IEC 62304, ISO 26262, ISO 21448, and ISO 21434, across various industries (automotive, nuclear, aerospace, medical, etc.) through safety and process consulting. |
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