GKMT Consulting

GKMT Consulting is a small business engineering office located in Vienna, Austria, providing management and consulting services related to medical technologies, product development, quality management, and EPCM solutions in complex environments. Our goal is to generate value for our customers by facilitating solutions, managing teams, optimizing processes, providing technical expertiese, and empowering teams in their transition to reaching optimal performance. * Project Management services (PMI trained); * EPCM project services for complex facilities and systems - Environmental impact assessment experience * Certified Lead Auditor services for Quality Management Systems ISO 13485 * Functional and Basic Safety engineering and consultancy IEC 60601-1, IEC 60601-2-64 * Risk Management for Medical Devices ISO 14971, FMEA, FMECA * Test Management for Medical Devices * Medical Software Lifecycle consultancy IEC 62304 * Medical Device Certification and Approval consultancy EU MDR, US FDA * Technology consultancy in Physics, Electrical & Software Engineering, Radiotherapy, Particle Therapy, Ion beam physics, radiation protection, and more