ABSTRACT
Standards making organizations can be classified as being international, national, professional in nature or sector specific. Some of the sector specific areas that have written software standards include: defense, financial, medical, nuclear, and transportation. Despite the relatively unproven nature of software standards, an entire infrastructure already exists, and grows each year, to support the use, implementation, conformance and competency based on the emerging software standards. For software medical device manufacturers, the 1987 Good Manufacturing Process Regulation defined quality assurance activities as fully integrated and independent. International Organization for Standardization/ International Electrotechnical Committee 12207 has been established as the Food and Drug Administration's (FDA) baseline standard for software. It is the only standard currently on the FDA's list of recognized consensus standards for software. The Software Committee of the Association for the Advancement of Medical Instrumentation has taken on the task of drafting an adaptation of the 12207 standard for use in the medical device business sector.
