Everyone on
the same page.
Everyone works on the same documents in real time — your team and your outside consultants — while you control exactly who sees what.
The CardioFlex Catheter System is substantially equivalent to predicate K211045 — a steerable RF ablation catheter cleared in 2021.
Performance testing demonstrated equivalent tensile strength
Google Docs-style editing, with regulatory context baked in.
Your whole team edits the same document at once — live cursors, instant updates, and no more emailing Word docs back and forth.
- Live cursors and section locking
- Threaded comments with suggested-edit mode
- Version snapshots at every milestone
Hand a Superagent thread to a colleague — context and all.
You spent the time building the context with Superagent. Don’t lose it in an email. Share the thread, and your colleague picks up exactly where you left off.
- Full thread history shared in one link
- Anyone can continue or branch the thread
- All citations and context travel with it
Invite your consultant. Don’t expose your whole workspace.
Your outside consultant only needs the sections you assign — not your entire workspace. Share down to the section level, and stay in control of everything else.
- External users see only what you share — nothing else
- Set comment-only, suggest, or full-edit per person
- No Complizen account needed for outside reviewers
- Every external action logged in the audit trail
Everyone plays their part. Nothing bleeds over.
RA lead, engineer, QA reviewer, outside consultant — each role gets sensible defaults out of the box, adjustable down to the section.
- 4m agoJamesRA LeadApproved Section 14 — Performance Testing for submission
- 28m agoSarahExternalLeft a comment on Indications for Use
- 1h agoMayaEngineerEdited Substantial Equivalence · 12 changes
- 2h agoRaviQA ReviewerMarked Risk Management Plan ready for review
- 3h agoJamesRA LeadShared Section 7 with external reviewer