Track FDA Medical Device
Compliance Requirements
Monitor FDA regulations, track compliance deadlines, and generate audit-ready documentation — all in one dashboard built for medical device teams.
Start Free Trial — $19/moNo credit card required to start. Cancel anytime.
Regulation Monitoring
Automated alerts when FDA regulations change or new guidance is published.
Deadline Tracking
Never miss a submission deadline with smart calendar reminders.
Audit Documentation
Generate 510(k), PMA, and QSR-ready documents in minutes.
Simple, Transparent Pricing
Pro Plan
per month
- ✓ Unlimited compliance tasks
- ✓ Real-time FDA regulation alerts
- ✓ Audit-ready document generation
- ✓ 510(k) & PMA deadline tracking
- ✓ Team collaboration (up to 5 users)
- ✓ Priority email support
Frequently Asked Questions
Which FDA regulations does this cover?
We cover 21 CFR Part 820 (QSR), 21 CFR Part 807 (510(k)), PMA requirements, UDI compliance, and MDR reporting deadlines. Coverage is updated as FDA publishes new guidance.
Can I export documents for audits?
Yes. Generate and export compliance reports, gap analyses, and audit trails as PDF or Word documents, formatted to FDA submission standards.
Is my data secure and HIPAA-compliant?
All data is encrypted at rest and in transit. Our infrastructure is SOC 2 Type II certified and designed to meet HIPAA requirements for regulated industries.