This chapter is taken from the book Combination Products: Implementation of cGMP Requirements

This document discusses the complications related to developing combination products and gives details that help manufacturers understand risks and meet the regulatory requirements for such products.

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Edwin Bills is an ASQ Fellow, ASQ Certified Quality Engineer, ASQ Certified Quality Auditor, and ASQ Certified Manager of Quality/Organizational Excellence. He is also Regulatory Affairs Certified by the Regulatory Affairs Professionals Society. Mr. Bills holds Bachelors and Masters Degrees from the University of Cincinnati and is on the adjunct faculty of the Virginia Tech Graduate Health Products Risk Management Program, Blacksburg, VA. He also serves on the US national committee sponsored by AAMI, committee QM/WG04 application of risk management to medical devices, and assisted the international technical committee in development of ISO 14971. Mr. Bills has over 25 years experience in the medical products industry and was formerly Principal Consultant for Bilanx Consulting LLC, Sumter, SC and is currently Principal Consultant for ELB Consulting.