Consultys Medical GmbH – Enhancing Life Sciences, part of the Vulcain Engineering Group, is a specialized consulting company for medical devices and in vitro diagnostics, focusing on Quality Management, Regulatory Affairs, and Clinical Affairs. The company supports manufacturers throughout the entire product lifecycle – from initial concept and development through to successful approval and registration – and provides guidance on all regulatory matters within a highly regulated environment. The aim is to develop sustainable, tailored solutions that are precisely aligned with customers’ needs. At the same time, Consultys Medical’s mission is to support clients in addressing regulatory challenges and to implement efficient and effective processes to ensure the quality, safety, and compliance of medical devices on a sustainable basis. Its service portfolio includes, among others, the implementation of quality management systems according to ISO 13485 and MDR/IVDR, support in conformity assessment procedures, international product registrations, development of regulatory and clinical strategies, conducting audits, as well as the preparation and maintenance of technical documentation including risk management, usability engineering, software documentation, clinical and biological evaluations, and post-market surveillance reports. In addition, the company provides consulting on relevant standards such as IEC 60601-1, IEC 62304, and IEC 62366, as well as offering related training services.