Device Consulting and Full-Service CRO. Certified according to ISO14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice and ISO9001:2015. Founded in 2006 by Helene Quie, Qmed Consulting is a full-service Contract Research Organization (CRO) based near Copenhagen, Denmark. We provide strategic consulting services in connection with device approval in Scandinavia (Denmark, Sweden and Norway) and internationally through our global alliance. We specialize in: Clinical Affairs Regulatory Affairs Quality Management Commercial Healthcare Concept and Design Development Training The driving force behind Qmed Consulting is our commitment to clearing the path for new medical devices and new ideas based on project management, best-in-class expertise in clinical trials, clinical development, regulatory affairs, quality management and commercial healthcare. Our recommendations are based only on services that are necessary to complement our clients’ own expertise and competences. When you partner with Qmed Consulting, you acquire direct access to our team of highly skilled professionals. Our team has more than 100 years of experience working in the field of medical device and IVD approval.