A robust DIOM can serve as the foundation for meeting FDA requirements and is a useful tool to ensure future iterations, changes, and re-visits to the initial design are clearly documented.
The document management system for medical device industry should help companies have control over critical activities such as
This presentation will cover the FDA regulations (21 CFR Part 820.198) regarding complaint handling, how to best approach complaints (including initiation, investigation, evaluation, and follow-up verification)
This presentation will cover the FDA regulations (21 CFR Subpart J) regarding CAPA, how CAPA should be integrated into other branches of your Quality Management System
This webinar will define what each of these terms mean as defined within the FDA 21 CFR Part 820, including "human translations" to these often hard-to-read regulations.