Qmed Mission and Vision

Everything you need to know

Qmed is a full-service global Contract Research Organization (CRO) and consultancy firm headquartered in Copenhagen, Denmark. Qmed holds ISO 9001 and ISO 14155 certifications, underscoring its commitment to excellence in the field of medical devices. Established in 2006 by Helene Quie, Qmed was founded with a a dedication to enhancing the well-being of patients through the conduct of clinical investigations and studies, primarily within medical devices. These guiding principles have been instrumental in Qmed’s continued growth and expansion throughout its storied history, persistently driving the company’s focus on specialization in regulatory affairs and the provision of high-level quality management support to medical device and In Vitro Diagnostic (IVD) companies.

At Qmed, we uphold the following guiding principles:


Our purpose is to pave the path for the approval of novel medical devices and medicinal products, thereby facilitating more efficient healthcare procedures. In doing so, we aim to enhance patient safety, health outcomes, and overall quality of life. By pursuing this purpose, we actively contribute to the success of inventors and investors alike.


We offer strategic consultancy services grounded in unparalleled expertise, experience, and competencies. Our team comprises dedicated professionals who are internationally recognized as advisors in medical device and medicinal product approvals, as well as experts in the CRO field and commercial healthcare. We are driven by results and unwavering motivation.


Our promise is to guide our clients towards success by adhering to international best practices. We prioritize close, personalized collaboration and offer device approval solutions that align with our clients’ best interests. Through these commitments, we aim to help our clients achieve their objectives effectively and efficiently.

Our Management

Helene Quie
Chief Commercial Officer, Founder & Senior Principal Advisor

Helene Quie has a degree in Science specialised within cell biology from the University of Odense. Helene has more than 25 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.

Vagn Alexandersen

Vagn Alexandersen has more than 20 years’ experience as CFO in small and large consulting companies. He holds a master’s degree in economics from the University of Odense, where he specialised in accounting and finance.

Stephanie John
VP of Clinical Affairs and Clinical Senior Principal Advisor

Stephanie John has 29 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.

Jens Johansen
Manager for Strategic Consulting and Senior Principal Advisor

Jens Johansen graduated from Zealand Academy of Technologies and Business and has since 1998 worked with Quality Assurance and Regulatory Affairs in the Medical Device industry with hearing aids, Medical Device Packaging and Implants.

He has acquired competences with auditing, Risk management, FDA approval process, Medical Device Regulation, Quality Management Systems and Regulatory Affairs.