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 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 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 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.