Regulatory Affairs: What's the biggest pain point in your 510(k) workflow?
Regulatory Affairs professionals—I'm curious about your experiences with 510(k) submisisons for new devices.
What's the single biggest pain point in your 510(k) process today?
Examples could be:
- Finding and organizing supporting documentation
- Predicate device comparisons
- Writing or reviewing sections
- Cross-functional coordination
- FDA feedback cycles
- Version control
- Something else entirely
If you had a magic wand and could eliminate one part of the process, what would it be?
u/Ahaas96 — 9 days ago