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Regulatory Affairs Intern
Regulatory Affairs Intern
Company: Foundation Medicine, Inc.
Company: Foundation Medicine, Inc.
Duration: June 2025 - September 2025
Duration: June 2025 - September 2025
Project: IVDR submission support for an in vitro medical device (IVD) product
Project: IVDR submission support for an in vitro medical device (IVD) product
Skills Gained
Skills Gained
Technical report writing:
Clinical Performance Study Report
Analytical Performance Report
European Union (EU) IVDR requirements for Companion Diagnostics (CDx)
Knowledge of IVDR 2017/746 performance updates
FDA IVD regulations for CDx products
Regulatory strategy for medical devices
Clinical and analytical performance study design
Communication of results to a multi-disciplinary team
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