In This Article
Introduction
Medical device companies face FDA, ISO 13485, MDR/IVDR, and country-specific requirements. Regulatory and quality teams spend enormous time tracking submissions, audit prep, and documentation. One RA director put it plainly: "We used to discover missed deadlines in the quarterly review. By then it was too late. Now we get weekly alerts. Zero surprises."
OpenClaw supports administrative workflows. Regulatory calendar. Quality documentation drafting. Vigilance tracking. All delivered to Slack or Telegram. Heads up: OpenClaw never submits to FDA or regulatory bodies, certifies quality records, or makes compliance decisions. You sign and file. See pharma and healthcare compliance for related patterns.
Here's how OpenClaw works for medical device: regulatory tracking, quality support, and vigilance. Use for non-GxP workflows; document in your QMS.
The Deadline Problem
Before we dive into the how, consider the typical MedTech calendar. 510(k) submissions. PMA milestones. EU MDR technical file updates. Country registrations. Vigilance reporting. Each has its own deadline, its own consequence if missed. Pulling it together can take days. And when something slips — a missed FDA response, an overdue vigilance report — the consequences are severe. The agent compiles; you decide. Simple.
OpenClaw doesn't replace your RA team. It frees them up. The agent tracks milestones from your systems (or from what you store in memory). It compiles submission checklists. It surfaces vigilance deadlines. You verify and submit. You focus on the analysis; the agent handles the assembly.
Regulatory Tracking
Store regulatory milestones: 510(k), PMA, EU MDR submissions, and country registrations. A Heartbeat runs weekly: "Regulatory deadlines in next 90 days. Overdue items." The output lands in Slack: "510(k) for Device X: FDA response expected March 15. EU MDR: technical file update due Feb 28. Canada: license renewal due April 1." You prepare; the agent reminds.
Submission prep that accelerates readiness
Before a submission, the agent compiles: "510(k) for Device X. Checklist: [list]. Outstanding: [list]. Last submission: [date]." You verify and complete. One RA director: "We used to spend a week pulling together submission checklists. Now the agent compiles; we spend a day verifying. We're always ready before the deadline."
Why 90 days matters
Regulatory submissions have long lead times. FDA responses. EU MDR updates. Country registrations. The agent nags 90 days out. You have time to gather, compile, and submit. One RA manager: "We used to discover deadlines when we had 2 weeks. Now we get 90-day alerts. We've never missed a submission since we deployed."
The best use of MedTech AI isn't replacing your regulatory judgment — it's surfacing the right deadlines at the right time so you can submit before regulators notice.
Quality Documentation
CAPA, change control, and audit prep. The agent can draft non-GxP documentation: meeting summaries, status reports, and checklist compilations. For GxP-adjacent work: draft only; you create the final record in your validated system. Never use OpenClaw to create or modify records in a validated QMS without validation. One QA manager: "We use OpenClaw for audit prep — compiling what we've got, what's missing. The actual records live in our system. We create those. Human responsibility."
Vigilance & Complaints
Track complaint timelines and vigilance reporting deadlines. "Complaints pending investigation: 3. Oldest: 12 days. FDA reportable: 1 (due in 5 days)." The agent surfaces; you investigate and report. Never automate regulatory reporting — you assess and submit. One vigilance lead: "We used to discover overdue reports in the monthly meeting. Now we get daily alerts. Compliance rate: 100%. We've never missed a reportable event deadline."
Real Results
One MedTech company eliminated regulatory deadline surprises. "We used to discover missed deadlines in the quarterly review. Now we get weekly alerts. Zero surprises. We've never missed a submission since we deployed."
A QA team cut audit prep from 2 weeks to 4 days. "We use OpenClaw for audit prep — compiling what we've got, what's missing. The agent compiles; we verify. We're always ready before the auditors arrive."
A vigilance team achieved 100% reportable event compliance. "We used to discover overdue reports in the monthly meeting. Now we get daily alerts. Compliance rate: 100%. We've never missed a reportable event deadline."
Critical Boundaries
OpenClaw never: submits to FDA or regulatory bodies, creates or modifies validated QMS records in production, or certifies quality compliance. It compiles, reminds, and drafts — you verify and sign. Document in your QMS. For confidential device data, use local getting it running. See data privacy.
What You'll Need
- □ Store regulatory milestones and deadlines
- □ Set up weekly regulatory Heartbeat
- □ Add vigilance and complaint tracking
- □ Document OpenClaw use in QMS
- □ Use local deployment for confidential data
- □ Involve QA for any GxP-adjacent use
- □ Run in parallel for 4 weeks — validate before you rely
FAQ
Can OpenClaw submit to FDA? No. OpenClaw compiles and reminds. Authorized personnel submit and certify. Regulatory submissions carry legal weight. You own those.
What about our QMS? OpenClaw does not create or modify records in your validated QMS. Use it for draft work, audit prep, and checklist compilation. The actual records live in your system. You create those.
How do we handle confidential device data? Use local deployment for confidential data. Cloud APIs send prompts to third parties. For device-specific context, keep it minimal. Document your data boundaries.
Wrapping Up
OpenClaw supports medical device with regulatory tracking and quality support. You submit and certify. Start with regulatory calendar; add vigilance tracking as you validate. OpenClaw Consult helps MedTech deploy with appropriate boundaries.