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Dr. Isabella Steffensen
President at Thera-Business


Dr. Steffensen is a biomedical scientist with a B.Sc. Honours Biology (cum laude) and Ph.D. in Cellular Biology from the University of Ottawa. She completed a postdoctoral fellowship with a leading neurologist at the Ottawa Health Research Institute where she performed research on stroke and spinal cord injury. Over the past 20+ years, Dr. Steffensen has assisted pharmaceutical, medical device, biotechnology and diagnostic companies with regulatory, marketing, technical, and business development issues. She has widespread experience preparing regulatory documents, as well as other evidence based-reports such as practice guidelines and systematic reviews. Dr. Steffensen has completed hundreds of projects in the life sciences sector, embracing biotechnology, pharmaceuticals and bio-pharmaceuticals, medical devices, technology and diagnostics. She is a specialist at Clinical Evaluation Report remediation and helping medical device companies fulfill current regulatory requirements in the European Union. Dr. Steffensen is responsible for the overall operations and performance of Thera-Business, where she mentors a highly-skilled group of executives and staff. She is a well-respected leader with the strategic foresight to develop and promote a compelling vision for the future of Thera-Business.

Agenda Sessions

  • Optimal Use of Scientific Literature to Ease Your Path to EU MDR Compliance