The development of medical device, hardware and software is strongly linked to risk management and compliance with safety requirements according to international standards. Whether you need consultancy, support or training – Lorit Consultancy supports your team with its extensive international expertise in safe product design, hardware and software development. International standards we work with: ISO 14971, IEC 60601, IEC 62366, IEC 62304, AAMI TIR57
The accredited testing laboratory in accordance with EN ISO 17025 and inspection body in accordance with EN ISO 17020 of HygCen Austria GmbH is committed to the quality assurance of medical devices with the objective of the benefit to patients. HygCen Austria GmbH is internationally recognized and the tests are done according to national, European (EN), and international (ISO) standards.