Introduction to Medical Combination Products

This course covers current FDA regulatory compliance with respect to developing and marketing Combination Products. A focus is placed on relevant aspects of FDA regulations as well as the practical aspects of getting the Combination Product to market. Several example products will be highlighted to provide practical, hands-on instruction.

The first part of the course provides general context for the overall topics surrounding combination products. Later, a more in-depth discussion on implementation within a complete combination product development environment is presented. FDA’s regulations, guidance documents, and on-line informational resources will be highlighted and used throughout the course.

Byron W. Larson is President of Toltec Inc., a consulting firm specializing in medical-device product development and consulting. He has worked in the medical-device industry for nearly 30 years.

Prior to the formation of Toltec, Mr. Larson was responsible for US Research and Development operations for Gambro Renal Care Products.

Mr. Larson earned his BSME from Colorado State University and his MSME from the University of Colorado. Mr. Larson is certified by the State of Colorado as a Professional Engineer and by the Project Management Institute as a Certified Project Manager.

Mr. Larson is an inventor and co-holder of four United States and two international patents.