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

Cut Your MDR Compliance Assessment From Months to Days

AI-powered compliance gap analysis trusted by regulatory affairs teams at innovative medtech companies. Upload your IEC 62304, ISO 14971, and QMS documentation—get instant, audit-ready GSPR checklists.

Free forever for 1 product
Save €50k+ vs. consultants
Audit-ready in days, not months

No credit card required • Free forever for 1 product

ISO 27001 Certified

GDPR Compliant

EU Data Hosting

Still Preparing for MDR Compliance Manually?

Traditional compliance assessment is slow, expensive, and error-prone

6-12 weeks

Manual Gap Analysis

Regulatory teams spend months cross-referencing requirements across IEC 62304, ISO 14971, and GSPR chapters

€50K-€200K

Consultant Fees

External compliance consultants charge premium rates for documentation gap assessments

78% miss gaps

Hidden Non-Conformities

Manual reviews frequently miss requirement gaps that surface during notified body audits

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
Drag & Drop Files or click to browse
Compliance Gap Analysis Requirements Coverage by Category
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 Checklist Auto-generated from documentation
85%
Complete
12
Gaps Found
45
Documents
Risk Management 90%
Clinical Evaluation 75%
Post-Market Surveillance 60%
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
5x
Cheaper than Greenlight Guru
€50K+
Saved vs. consultants
Days
To first compliance insights

Ready to Accelerate Your MDR Compliance?

Join innovative medtech companies saving €50k+ on compliance with AI-powered gap analysis.

No credit card required • Free forever for 1 product

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