The U.S. Food and Drug Administration issued a Federal Register notice with a proposed program for Voluntary Malfunction Summary Reporting. When finalized, this program would allow manufacturers to report certain malfunction medical device reports (MDRs) in a summary format on a quarterly basis instead of individually within 30 days. The proposed Voluntary Malfunction Summary Reporting...Read More
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.