Designing and testing products to meet the requirements of regulatory agencies

Abstract

Conventional engineering and engineering technology courses may teach students how to design functional products, but almost never address the very practical problem of meeting regulatory requirements. The paper discusses actual instrumentation and some of the design specifications and modifications that were implemented to meet the requirements of various regulatory agencies. Both hardware and software considerations are discussed. Requirements to gain approval from the following agencies are considered: 1. Underwriter Lab Listing (UL). 2. Third party testing agencies. 3. FDA for Laser Safety. 4. Compliance engineering (C.E. Marking). 5. R.F. and EMI testing. 6. FDA Premarket Notification, 510 k. An understanding of the requirements from regulatory agencies leads to better product design and reduces product development time. Case histories of actual products that were submitted by the author and approved by various regulatory agencies are presented.