MedTech Compliance Automation

Accelerate Compliance. Eliminate Risk.
The Future of MedTech QA.

The Problem

Traditional risk analysis (ISO 14971) is the bottleneck of MedTech innovation. It is manual, slow (40-150 hours), and prone to human error, leading to avoidable audit findings and delayed market entry.

The SIFo Solution

We combine advanced AI automation with comprehensive regulatory and risk management experience. Automated hazard identification, and traceability allow your engineering team to focus on patient safety, not paperwork.

80–95% Faster

Reduced documentation time

Audit-Ready

Aligned with MDR & ISO 14971

Traditional vs. SIFo AI‑Assisted

Why industry leaders are switching to automated compliance.Traditional

Traditional

  • • 40–150+ hours per file
  • • Team of 3–6 people required
  • • Manual brainstorming & high meeting density
  • • Inconsistent terminology & audit risks
  • • Delayed time‑to‑market
The New Standard

AI‑Assisted

  • 2–10 hours total review time
  • Single expert review required
  • Automated hazard ID & control suggestions
  • 2–10 hours total review time
  • 80–95% time savings

ROI Calculator

Input Variables

Cost Traditional

0 €

Projected Savings

0 €

per Analysis

Hours Saved

0 h

ROI Factor

0%

*Calculation assumes 5 hours of internal review time.

Flexible Pricing Models

Transparent costs. High precision. No hidden fees.

Single Analysis

3,000 €

For Start-ups & Small Manufacturers

  • AI-powered Risk Analysis
  • Standardized Hazard IDs
  • ISO 14971-Aligned Output
  • Raw Data Delivery
Get started
Most Popular

AI + Expert Review

4,997 €

For SMEs including Expert Support

  • Includes Single Analysis
  • 3h Senior RM Expert Review
  • Risk Documentation Enhancement
  • Audit-Resilient Review
Get started

Subscription

From 15,000 €

For Enterprise & High Volume

  • Standard: 12 Analyses (15k€)
  • Pro: 20 Analyses (22k€)
  • Fair Use: 30 Analyses (30k€)
  • Priority Support
Contact Sales