Our management

Everything you need to know

Qmed is an ISO 9001 and ISO 14155 certified medical device CRO that was founded in 2006 by Helene Quie who had a passion for “enabling better health” to patients through high quality clinical investigations and studies primarily of medical devices. These principles have helped Qmed grow and expand during its many years of history and remain of key focus for the company together with specialization within regulatory and quality management support for medical device and IVD companies.

At Qmed we have the following mantra:

Pave the way for new medical device and medicinal products approvals that enable more efficient healthcare procedures while improving patient safety, outcomes and quality of life, thus helping inventors and investors achieve success

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 and medicinal products approval advisors, CRO specialists and commercial healthcare experts

Help create success for our clients based on international best practices, close personal collaboration, and device approval solutions that serve their best interests

Helene Qmed Image
Helene Quie
Chief Commercial Officer, Founder and Senior Principal Advisor

Helene Quie has a degree in Science specialised within Cellbiology 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

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.

Management Stephanie John
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 Qmed
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.