Transform your ideas into revenue with a wide range of worldwide strategic services and support for medical device and IVD companies.
*CQMS is ISO 14155:2020 and ISO 9001:2015 certified
At Qmed Consulting we believe that the only way to ensure the best solution for all concerned is to base our recommendations and activities on the real needs of our clients.
Our focus is on supplementing your own expertise and competences, not replacing them. That means that when you partner with us you can be sure that we will only propose activities for which you either do not have sufficient resources, or that you would prefer us to accept responsibility for in order to free up your own resources for other tasks.
We offer strategic consulting services based on best-in-class knowledge, experience and competences from a result-oriented and highly motivated team of international medical device strategic advisors, CRO specialists and commercial healthcare experts. Our clinical team are experts in monitoring and designing studies to ISO14155 and GCP.
Our purpose is to be part of the team that successfully paves the way for new medical device approvals that enable more efficient procedures while improving patient safety, outcomes and quality of life, thus helping inventors and investors achieve success.
Qmed Consulting is a trusted partner to Top 40 medical device companies and global CROs since its establishment in 2006
Helene Quie has a degree in Science specialised within cellbiology from the University of Odense. Helene has 20 years of experience within the pharma and medical device industries working for inter alia Cook Medical A/S, H. Lundbeck A/S, AMBU A/S and Millimed A/S. Her primary expertise is within the clinical and regulatory areas such as device development, quality management, project management, clinical trial execution, market access and general management. In 2006 she founded Qmed Consulting as a private consultancy company providing services within medical device development and clinical trials.
Stephanie John has 17 years of experience within the Medical Device Industry. She holds a PhD in Microbiology from the University of Manchester and has worked for both CROs and medical device start-up companies in the field of Clinical and Regulatory.
Her previous work includes cardiovascular surgery, vascular surgery, interventional cardiology, interventional neuro radiology, middle ear implants (active implantable), intensive care studies, gynaecology and orthopaedics. She speaks French and German on a daily basis.