Q
Industry Focus

Medical Devices Industry Strategy

Specialized marketing for Qt's QA suite in medical device software - addressing IEC 62304, FDA compliance, and the unique demands of life-critical systems.

90%
Top MedTech Companies Use Qt
$75B
Medical Device Software Market by 2030
100%
Class II/III Devices Require IEC 62304
18-36mo
Average FDA Approval Timeline
Market Opportunity

Medical Device Software: Mission-Critical Quality

Regulatory complexity and life-critical stakes make software quality non-negotiable in medical devices

Industry Drivers
Software as a Medical Device (SaMD)
AI-powered diagnostics, remote patient monitoring, and digital therapeutics
Connected Medical Devices
IoMT (Internet of Medical Things) requires robust cybersecurity and validation
Regulatory Evolution
FDA, CE Mark, MDR (Medical Device Regulation) becoming more stringent
Patient Safety Imperative
Zero tolerance for software defects - lives are at stake
Critical Challenges
IEC 62304 Compliance Complexity
Extensive documentation and traceability requirements
FDA Submission Pressure
510(k) and PMA processes demand exhaustive test evidence
Risk Management (ISO 14971)
Software hazard analysis and risk mitigation verification
Post-Market Surveillance
Ongoing monitoring and adverse event tracking requirements
Qt's Medical Device Advantage
Why Qt QA Suite is trusted by 90% of top MedTech companies
IEC 62304 Ready
Tools qualified for use in regulated environments with compliance documentation
Proven in Life-Critical Systems
Siemens Healthineers, GE Healthcare, and other leaders trust Qt for patient-facing devices
Audit-Ready Traceability
Complete test evidence and requirements traceability for regulatory submissions
Target Accounts

Medical Device Account Segmentation

Strategic targeting of medical device OEMs, diagnostics companies, and digital health innovators

Tier 1: Global MedTech Leaders
Top 15 medical device manufacturers
Imaging & Diagnostics
  • • Siemens Healthineers (existing ✓)
  • • GE Healthcare
  • • Philips Healthcare
  • • Canon Medical Systems
Surgical & Monitoring
  • • Medtronic
  • • Johnson & Johnson MedTech
  • • Abbott Laboratories
  • • Boston Scientific
In Vitro Diagnostics
  • • Roche Diagnostics
  • • BD (Becton Dickinson)
  • • Danaher (Beckman Coulter)
Tier 2: Specialty Device Makers
Mid-market and specialty devices
Core Targets (20 accounts)
  • • Stryker
  • • Zimmer Biomet
  • • Edwards Lifesciences
  • • Intuitive Surgical
  • • Dexcom
  • • Insulet
  • • Tandem Diabetes Care
  • • ResMed
  • • Masimo
  • • Hill-Rom (Baxter)
Tier 3: Digital Health Innovators
SaMD and connected health
Emerging Targets (15 accounts)
  • • Livongo (Teladoc Health)
  • • Omada Health
  • • Butterfly Network
  • • Caption Health
  • • Viz.ai
  • • Eko Health
  • • Tempus
  • • PathAI
  • • Arterys (acquired)
  • • Zebra Medical Vision
Key Buyer Personas in Medical Devices
Regulatory Affairs Manager
Primary buyer for IEC 62304 compliance and FDA submission tools
Pain Points: FDA submission delays, audit readiness, documentation burden
Messaging: Compliance automation, pre-qualified tools, audit confidence
Quality/QA Director
Responsible for software verification and validation processes
Pain Points: Test coverage gaps, risk-based testing, traceability
Messaging: Requirements traceability, risk-based testing, defect prevention
VP R&D / CTO
Strategic decision-maker balancing innovation and compliance
Pain Points: Time-to-market pressure, regulatory delays, quality vs. speed
Messaging: Faster submissions, integrated platform, risk mitigation
Content Strategy

Medical Device Content Library

Compliance-focused content addressing regulatory and quality challenges

Regulatory & Compliance Content
Resources for navigating medical device regulations
Whitepaper: "IEC 62304 Compliance: A Practical Guide for Medical Device Software"
Checklist: "FDA 510(k) Software Documentation Requirements"
eBook: "Risk-Based Testing for Medical Device Software"
Video Series: "Medical Device Software Lifecycle Best Practices"
Webinar: "Accelerating FDA Submissions with Automated Testing"
Case Studies & ROI Evidence
Success stories from medical device leaders
Siemens Healthineers Case Study
"Ensuring Software Quality Across Medical Imaging Portfolio"
Existing Customer
Class II Device Manufacturer
"Reducing FDA Submission Time by 6 Months with Automated Traceability"
Anonymous Case Study
SaMD Startup Success Story
"First-Time FDA Clearance with Zero Major Deficiencies"
Digital Health Company
Medical Device Webinar Calendar (Q1 2025)
January: "IEC 62304 Compliance Made Simple"
Target: Regulatory Affairs, QA Directors
February: "Risk-Based Testing for Medical Devices"
Target: QA Engineers, Software Verification Leads
March: "Software as a Medical Device (SaMD) Testing Strategies"
Target: Digital Health Companies, AI/ML Engineers
Value Proposition

Qt QA Suite: Medical Device Value Proposition

How Qt accelerates FDA submissions while ensuring patient safety

For Regulatory Affairs
Streamlined compliance and faster submissions
Pre-Qualified Tools
IEC 62304 compliance documentation included - reduce auditor questions by 40%
Requirements Traceability
Automated traceability matrix from requirements → tests → results
Audit-Ready Reports
Generate FDA/notified body submission packages in minutes, not weeks
Impact:
Reduce FDA submission preparation time by 30-40%
For Quality/QA Teams
Comprehensive testing and risk mitigation
Risk-Based Testing
Prioritize testing based on ISO 14971 hazard analysis and software safety classification
100% Code Coverage Visibility
Meet IEC 62304 Class C requirements for statement and branch coverage
Regression Testing Automation
Catch defects early in development, not during validation or post-market
Impact:
Reduce post-release defects by 60-80%, minimize field corrections
Quantified Business Impact for Medical Device Companies
6-12mo
Faster Time-to-Market
Accelerated FDA submissions
30-40%
Reduced Submission Prep
Automated documentation
60-80%
Fewer Post-Launch Defects
Early defect detection
€500K+
Savings per Product
Reduced recall/correction costs

Trusted by 90% of Top MedTech Companies

When patient safety is non-negotiable, medical device leaders choose Qt's QA suite for comprehensive software quality and regulatory compliance.

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