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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:
PURPOSE
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.
PROPOSITION
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.
PROMISE
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.
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 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.
Rachel has extensive experience and expertise in clinical management and consultancy in the medical device and pharmaceutical industries. Rachel has a strong background in human relations and project management and is knowledgeable in GCP/ICH, ISO14155 and regulatory compliance guidelines for clinical trials. She has provided clinical management consultancy and support to the medical device and pharmaceutical industries, including feasibility studies, research, regulatory studies, post-marketing studies and phase I-IV trials.
Rachel has also provided clinical strategy and support to medical device companies, guiding them in the planning and conduct of clinical studies and assisting with EC/CA submissions and monitoring.
In addition to her professional experience, Rachel has a BA in Biomedical and Clinical Chemistry and has completed courses in leadership, negotiation, quality assurance, NLP (Neuro-Linguistic Programming) and regulatory training.
Esther is an experienced Vice President of Medical & Regulatory Affairs with extensive expertise in developing and executing global clinical and regulatory strategies for medical devices. Esther has demonstrated success in leading clinical trials, managing regulatory submissions and fostering collaborations with key opinion leaders across Europe, Canada and the US. Currently, Esther is directing clinical and regulatory initiatives at TRiCares GmbH.
She previously held senior executive positions at CorFlow Therapeutics AG, Edwards Lifesciences LLC in Advanced Technology and Biotronik AG in Vascular Interventions. Additionally, Esther provides strategic advisory services in medical and regulatory affairs for DVMMD Consulting and serves as a board member in various medical device companies and CROs.
Professor Dr. Marianne Brodmann is a leading vascular specialist and professor of internal medicine at the Medical University of Graz, Austria. She completed her medical degree, residency, and fellowship training at the University of Graz, focusing on vascular medicine. She served as Secretary and Chairperson of the working Group Peripheral Circulation of ESC and was President of the ÖGIA from 2012-2014 and President of The European Society of Vascular Medicine (ESVM) from 2017-2018. She has also been a National Delegate of the International Union of Angiology (IUA) since 2005.
Her research interests include anticoagulation and thrombolysis, cutting-edge endovascular technologies in peripheral interventions, and the mechanisms underlying restenosis.
A contributor to over 50 global clinical trials, Dr. Brodmann has authored numerous high-impact publications and is a sought-after speaker at international conferences. Dr. Brodmann also serves on the editorial boards of leading journals and is dedicated to mentoring the next generation of vascular specialists.
Professor Dr. Michael Joner is an interventional cardiologist who has been appointed as Professor in Cardiology at the Deutsches Herzzentrum Muenchen (DHZ) after having served as Chief Executive Officer at CVPath Institute, Gaithersburg, Maryland, USA. He graduated from medical school at University of Wuerzburg, Germany in 2003, followed by a research fellowship in cardiovascular pathology. After that he returned to the DHZ to complete his cardiology and interventional cardiology training. Dr. Joner serves as a member of the European Association of Percutaneous Coronary Intervention and is faculty member of major medical congresses.
Dr. Joner’s main research interest is the translation of pathological findings in cardiovascular disease into clinical practice. Research awards received include the Young Investigator Award 2013 at CRT 2013 and an award for the best Habilitation at the Technical University of Munich.
Dr. Waksman is the Associate Director of the Division of Cardiology and the Director of Cardiovascular Research and Advanced Education for the MedStar Heart and Vascular Institute at the MedStar Washington Hospital Center (MWHC).
With nearly 20 years of experience in leading edge medical technologies, Dr. Waksman is a world-renowned interventional cardiologist and a highly sought-after principal investigator for pre-clinical and clinical studies conducted in the United States and abroad.
His current research interests include brachytherapy for restenosis prevention bioabsorbable/ biodegradable stents, HDL therapy, intracoronary imaging, valvular heart disease and catheter-based treatment of renal denervation, which has resulted in over 1,200 manuscripts published in peer reviewed journals. In addition to his research interest, Dr. Waksman is also the Editor-in-Chief of the CRM Journal and the Course Director for the CRT Meeting.
Koebmagergade 53, 1.
DK-1150 Copenhagen K.
Denmark
+45 56 64 10 10
info@qmed-consulting.com
Proud sponsors of
Red Cross and Mothers Aid.
Qmed Consulting is an ISO 9001:2015
& 14155:2020 certified company.
