Title 21 of the Code of Federal Regulations (CFR) covers the broad area of food and drugs, but Part 820 pertains to
quality systems for medical devices. It outlines Current Good Manufacturing Practice (CGMP) regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. These requirements are meant to ensure that medical devices are safe, effective, and in compliance with the Federal Food, Drug, and Cosmetic Act. ISO 13485:2003 is an international standard that specifies requirements for regulatory purposes for medical device manufacturers. It provides a framework for companies to meet their customer and regulatory requirements. The main goal is to provide a harmonized model for quality management system requirements in the international market since different countries might have different standards. ISO (derived from the Greek word isos, meaning equal) refers to the International Organization for Standardization, a non-governmental organization based in Geneva.
