New: Automated GSPR Annex I checklist generation now available Learn More
CaptainCompliant
For Medical Device Software Companies

Stop Guessing If You'll Pass Your Audit

Upload your IEC 62304 and ISO 14971 docs. See exactly what's missing—before your notified body does. Get a complete GSPR gap report in 48 hours.

Free for your first product—forever
48 hours to your first gap report
No consultant required

No credit card • No sales calls • Just upload and go

ISO 27001 Certified

GDPR Compliant

EU Data Hosting

The Real Cost of Gap Analysis Done Wrong

Most teams don't realize what compliance delays actually cost them

3 Months

Of Your Runway

That's what most teams burn just figuring out what documentation they're missing. Meanwhile, patients wait.

€75,000

For a PDF

That's what consultants charge for gap analysis. Most of it goes to people who leave you with a report and a handshake.

"We Need More"

The Dreaded Email

3 in 4 audits come back with additional evidence requests. What if you found those gaps before they found you?

Simple 4-Step Process

From Document Upload to Audit-Ready Compliance

Our AI-powered platform analyzes your technical documentation and generates comprehensive GSPR gap reports

Step 1

Upload Your Documentation

Drag and drop your IEC 62304 software development files, ISO 14971 risk management documentation, and quality management system procedures. Supports PDF, Word, and Excel.

  • Secure encrypted upload (AES-256)
  • Automatic document categorization
  • Version control and audit trail
PDF
DOCX
XLSX
Drop files
Compliant
3 Gaps
Analyzing
AI analyzing 23 GSPR chapters
Step 2

AI-Powered Gap Analysis

Our AI engine cross-references your documentation against all 23 GSPR chapters, identifying missing requirements, incomplete evidence, and potential non-conformities.

  • Coverage analysis by GSPR chapter
  • Severity classification of gaps
  • Traceability to source documents
Step 3

Generate GSPR Checklist

Automatically generate a comprehensive Annex I GSPR checklist mapped to your documentation, ready for notified body submission or internal audit.

  • All 23 GSPR chapters covered
  • Evidence links and justifications
  • Export to Excel, PDF, or Word
GSPR Annex I
23 chapters
85%
Chapter 1: General Safety
5 requirements verified
Complete
Chapter 14: Software Safety
IEC 62304 compliance
Complete
Chapter 3: Risk Management
ISO 14971 mapping
2 gaps
Chapter 7: Clinical Evaluation
Pending analysis
Pending
Auto-generated from your docs Export ready
Compliance Dashboard
Live
Compliance Score
0 %
Gaps Remaining
0 of 47
Documents
0 analyzed
+42
IEC
92%
ISO
78%
QMS
95%
Real-time updates
Step 4

Track & Close Gaps

Use our compliance dashboard to assign, track, and close gaps with your team. Real-time progress monitoring ensures you're always audit-ready.

  • Team collaboration and assignments
  • Progress tracking by requirement
  • Audit trail for compliance evidence
0
Free tier forever
48 h
To first gap report
23
GSPR chapters mapped
0
Sales calls required
See The Difference

12 Weeks vs 48 Hours

Watch how your compliance journey transforms

Traditional Approach

12 weeks • €75,000+
Hire consultant
Kickoff meeting
Document collection
Manual review
Back & forth
Final report
vs

With Captain Compliant

48 hours • €0
11 weeks saved
Upload docs
AI analysis
Gap report ready

Same result. 12x faster. 75x cheaper.

Why Wouldn't You Try It?

We've removed every excuse. Seriously.

No credit card required

Sign up with email. That's it.

No sales calls

Upload your docs and see results. No demo required.

No complex setup

Drag, drop, done. Gap analysis starts automatically.

Keep your reports forever

Even on the free tier. Your analysis doesn't expire.

Getting Started Captain Compliant Traditional
Time to first insights 48 hours 6-12 weeks
Cost to try €0 €5,000+
Commitment None Months
The Team Behind Captain

Built by regulatory professionals who lived this pain

We're not another SaaS trying to sell you AI. We're compliance experts who built the tool we wished existed.

"We spent 14 weeks doing gap analysis manually for one client—only to have their notified body come back with 23 additional evidence requests. There had to be a better way."
25+ Years
in MDR & MDD compliance
100+
technical file reviews
50+
MDR certifications guided

Deep Domain Knowledge

IEC 62304
Software lifecycle processes
ISO 14971
Risk management
IEC 82304
Health software products
GSPR Annex I
All 23 chapters mapped

Worked With

BSI
TÜV SÜD
SGS
Dekra

* Experience working with technical documentation reviewed by these organizations

You've Read This Far. You Know You Need This.

The only question is whether you'll spend €75,000 and 12 weeks figuring it out—or 48 hours and €0.

No credit card • No sales calls • Just upload and go

Ready to see what's missing?

Free for your first product—forever.

See My Gaps