Medical device software development and product submissions
Subtitle: proceedings of the 1992 HIMA Conference
By: sponsored by the Health Industry Manufacturers Association, Washington, D.C., December 1-2, 1992.
Contributors: Health Industry Manufacturers Association.
Series: HIMA publication ;; 93-5
Publisher: The Association
Published: 1993
Place of publication: Washington, D.C. (1200 G St., N.W., Suite 400, Washington 20005)
Language: eng
Number of pages: 172
Subjects: Medical instruments and apparatus -- Software -- Congresses.
Other titles: Reviewer guidance for computer controlled medical devices undergoing 510(k) review.
Notes: Includes bibliographical references.
Includes Appendix B: Reviewer guidance for computer controlled medical devices undergoing 510(k) review / Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration.