Consultys medical GmbH

About Consultys medical GmbH

At Consultys medical GmbH, we are dedicated to consulting in the areas of quality management, risk management, regulatory affairs and development processes, with a special focus on supporting medical device manufacturers. Our goal is to guide these manufacturers through the complex process of obtaining CE or FDA approval for their products. We offer a comprehensive portfolio of services, including audits, assessments and inspections, as well as advice on compliance with regulatory requirements and standards. Our mission is to support our clients in overcoming regulatory challenges and implementing efficient and effective processes that ensure the quality and safety of their medical devices. At be-on-quality, we place great emphasis on assisting not only in meeting regulatory requirements, but also in developing sustainable solutions for quality management and product approval. Our support covers the full range of quality and regulatory requirements, from implementation to maintenance to audits and beyond, to enable a successful market launch of our clients' products.