Speakers at Medtech Copenhagen 2021
You will find the preliminary list of speakers here below. We make reservations for any changes in the programme.
Dr. med. habil. René Bombien
Internal Clinician, Medical Health Services, TÜV SÜD
Dr René Bombien obtained his medical degree from the Johann Wolfgang von Goethe University in Frankfurt and the Christian Albrechts University in Kiel of Schleswig-Holstein, and has been practising cardiovascular surgery for over 10 years. He received the board certification for cardiac surgery at the Ludwig Maximilian University Hospital in Munich, Bavaria. He holds a university teaching licence and has over 20 years experience in cardiovascular research, including research work at the Department for Cardiac Surgery of the Cedars Sinai Medical Centre in Los Angeles, California. Since 2013, he has been with the Clinical Centre of Excellence at TÜV SÜD MHS – started in the US, then in Germany. He has performed clinical assessments of medical devices according to MDD, AIMDD and MDR; mainly in the high risk implantable cardiovascular area for legacy as well as for highly innovative medical devices.
CEO, Qmed Consulting
Helene is 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.
Together with the Qmed team Helene has 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 the Qmed team and trusted partners in Europe, US, Canada, India and Australia.
Section Manager, Development of Medical Devices
As Head of Unit (section manager) and responsible for medical devices in the Danish Medicines Agency Jeppe works with public sector, MedTech-Industy and Patient-NGO’s to secure patient safety.
The Danish Medicines Agency
- Authorises and inspects pharmaceutical companies and licenses medicinal products in the Danish market
- Monitors adverse reactions from medicinal products
authorises clinical trials
- Decides which medicines are eligible for reimbursement
monitors medical devices available in Denmark and supervises adverse incidents involving medical devices
- Appoints proprietary pharmacists, organises the pharmacy structure and supervises pharmacies and retailers.
Founder, HFUX Research | Medical Human Factors
Boston, United States
A Human Factors Consultant with over 20 years of experience in the application of human factors science and usability practices in the product research and development industry. She founded HFUX Research in 2017, with the vision to empower organizations around the globe, at every budget, knowledge level, and development stage, to realize their human factors vision and usability goals, by employing customized human factors and usability strategies and solutions, tailor fit to each organizations’ R&D needs.
With her diverse professional experience as a trained pilot, emergency medical technician, software analyst, and human factors and usability expert within the medical device and combination product development industry, her motivation has been directed towards enhancing human-product performance by optimizing user interface design, information architecture, and user and product workflow, through the application of human factors science and usability guidelines and practices.
Frederik van Deurs
CEO, Green Innovation Group
Frederik is the CEO of Green Innovaiton Group A/S. Frederik has worked with and advised Novo Nordisk, Janssen, Trial Nation and the Danish Regions on green transformation of the health sector.
You can read GIG’s recent whitepaper on the topic here:
Marlene Winther Plas
Partner and Head of IPT, Denmark, DLA Piper
Marlene Winther Plas specialises in IT law and data protection and has more than 20 years’ experience in technology-related law. Marlene has in-depth knowledge of all major aspects of business law, including the legal and commercial challenges facing Danish and foreign enterprises. She is a qualified mediator and arbitrator and assists Danish as well as non-Danish enterprises and public authorities in the resolution of IT and commercial disputes.
Marlene is a certified IT attorney and specialises in IT law, assisting clients in eg the negotiation and preparation of complex IT contracts (supply contracts and systems procurement for the private and public sectors), IT outsourcing, development projects and major technology transactions. Marlene also deals with dispute resolution and litigation regarding IT supplies. Furthermore, Marlene has vast experience in data protection and data protection compliance projects and provides assistance to Danish and foreign enterprises and public authorities regarding compliance with data protection rules. Marlene is, moreover, head of DLA Piper Denmark’s IPT team and in-house Data Protection Compliance team. Since 2001, Marlene has been involved in political and professional activities within the legal sector. In 2008, she assisted in establishing the Association of Danish Law Firms and was its vice-chairman up until 2016; she also sat on the Committee of the Association of Danish IT Attorneys for a number of years.