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[Lecture] Covid-19 diagnostic tests: overview of the US, Canada and EU regulatory pathways
發稿日期: 2020-10-08
發稿單位: 生醫轉譯研究中心
After a thriving career in different Regulatory and Quality roles in startups and Fortune 500 companies, Dr. Fatehi decided to start her own business, QARALOGIC Consulting Inc., to help companies bring their medical innovation to patients in need. Dr. Fatehi is a RAC (Devices) holder, a certified (BSI) 13485:2016 Lead Auditor and a qualified PRRC (person responsible for regulatory compliance) for the EU-MDR/IVDR transition. In addition to the EU regulations, Dr. Fatehi supports companies with low to medium risk marketing applications in the US FDA and Health Canada.