BARDA Device Development for Scientists Training - (Request for Quotation)

Description: The Contractor shall provide qualified instructor(s) and all course materials necessary to conduct the training. Course materials may include presentation slides, participant workbooks, handouts, case studies, exercises, or other instructional materials appropriate for the course. Training Requirements and Learning Objectives: The Contractor shall provide training addressing, at a minimum, the following subject areas. Medical Device Discovery and Development. The training shall address: Discovery and development pathways applicable to diagnostics, therapeutics, and Software as a Medical Device (SaMD); Method-of-Use, Target identification and validation; Medical device discovery and concept development: Preclinical development; Development decision milestones and go/no-go criteria; Target product profiles; and Nonclinical studies. See attached file.