Comparison of the Quality System Requirements of Code of Federal Regulations Part 820 and International Standard ISO 13485

Abstract

This paper compares the quality system requirements of the Code of Federal Regulations 21 CFR part 820 with the quality system requirements of the International Standard ISO 13485. The medical devices industry that distributes product in the domestic (United States of America) market and in the international (European countries) market shall comply with the regulations (CFR 820 and ISO 13485:2003) and the harmonization of both requirements in one quality system is the ideal process to avoid the missing of any of the requirements. This comparison will help to understand the international and the domestic quality system requirements and the quality system maintenance. A guideline was developed for a sterile medical devices industry to implement a single quality system which includes international and domestic quality system requirements without the missing of any of the requirements.