References
- Food and Drug Administration, Center for Devices and Radiological Health. Draft Policy Guidance for Regulation of Computer Products. FDA, Rockville, Maryland 1987, 22 September
- Federal Food, Drug, and Cosmetic Act, as Amended. US Government Printing Office, Washington, DC 1976, October
- Food and Drug Administration, Center for Drugs and Biologics and Center for Devices and Radiological Health. Guideline on General Principles of Process Validation. FDA, Rockville, Maryland 1987, May
- Food and Drug Administration, Division of Field Investigations. Technical Reference on Software Development Activities. FDA, Rockville, Maryland 1987, July
- Food and Drug Administration, Center for Devices and Radiological Health. Reviewer Guidance for Computer-controlled Medical Devices. FDA, Rockville, Maryland 1988, Draft, 23 September
- Ghiassi M. Software quality: design it in from the start. Computer Design. 1984, August
- Food and Drug Administration, Center for Devices and Radiological Health. Preproduction Quality Assurance Planning: Recommendations for Medical Device Manufacturers. FDA, Rockville, Maryland 1989, Final Draft, March