FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.
Contract & Proposal Writer
Help a user set up Telegram for ehAye Dojo. Default to Personal private bots (recommended). Group setup is advanced for teams/observers/demos.
Use when you have a written implementation plan to execute in a separate session with review checkpoints
Use when implementation is complete, all tests pass, and you need to decide how to integrate the work - guides completion of development work by presenting structured options for merge, PR, or cleanup
Use when completing tasks, implementing major features, or before merging to verify work meets requirements
Use when executing implementation plans with independent tasks in the current session
Use when encountering any bug, test failure, or unexpected behavior, before proposing fixes