Commercialization of any medical device begins with a plan and the establishment of a product development strategy. What does the path look like for commercializing your medical device? CIMTEC’s objective for this webinar is to provide inventors/entrepreneurs with some of the key factors that must be considered when developing their commercialization plan, as well as best practices as they navigate their way through the process. In particular, the presentation will cover the areas of intellectual property, regulatory, reimbursement, market research, design and development, and clinical evaluations.
Presenter: Alvira Macanovic – CIMTEC, IP, Regulatory and Clinical Affairs Manager
Dr. Alvira Macanovic obtained a Bachelor of Science in Biochemistry from McGill University and a PhD in Chemistry in the field of diagnostics from Concordia University.
She started her career as a Research Scientist in the Immunochemistry department of a multi-national Contract Research Organization (CRO) managing studies for domestic and international clients. In that role, she gained practical knowledge of GxPs (GCPs, GLPs, GMPs), as well as regulatory guidelines, policies, standards and practices and requirements.
Prior to joining CIMTEC, Alvira worked as a scientific consultant for two Toronto law firms where she applied her regulatory knowledge to advise clients on regulatory requirements and in developing strategies for bringing products to market in regulated industries, including, medical devices, in vitro diagnostics, pharmaceuticals, biologics and biotechnology, natural health products and functional foods.
Alvira applies her vast knowledge and skill set at CIMTEC providing intellectual property and regulatory assessments, advice about the product development pathway in the medical imaging and device sector, as well as management of CIMTEC’s Clinical Testing Services.