Helene Quie
Chief Regulatory Officer
CEO at Qmed-consulting - experts in creating valuebased documentation for innovative medical devices getting access to the markets through strong and honest partnerships with our clients.
It is my vision to enable better health through close collaborations with large established or newly started medical device manufacturers, small venture based innovative companies, venture funds, notified bodies, hospital, doctors and nurses within a wide range of medical device products and concepts from high risk complex products such as heart valves with biological tissue to lower risk class products such as dental care products.
I believe that we through our trusted partners and colleagues can change the treatment of sick patients – making sure frontier products reach the patients and end-users, saving patient lives.
Together with the Qmed team I have provided advice and/or operational services for several clients since 2006 within clinical and regulatory affairs, quality management, reimbursement and health economics and market access with presence through our Qmed team and trusted partners in Europe, US, Canada, India and Australia.