How to Apply STRIDE Threat Modeling to Medical Devices
Step-by-step guide to implementing STRIDE methodology for medical device cybersecurity threat modeling, including practical examples and FDA submission tips.
Essential resources for compliant medical device software development
Expert guidance, checklists, and best practices to help you navigate FDA requirements, cybersecurity compliance, and regulatory standards.
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Essential checklists and guides for medical device software teams
Medical Device Quick-Start Guide
Comprehensive early-phase development guide covering the first 10-20% of your medical device journey. Essential guidance on regulatory requirements, user needs analysis, risk management, and cybersecurity compliance.
- • Intended use vs. indications for use framework
- • User needs to design requirements process
- • 15+ copy-paste templates for immediate use
- • ISO 14971 risk management guidance
- • FDA compliance best practices
FDA Cybersecurity Readiness Checklist
Comprehensive checklist covering all FDA cybersecurity requirements for medical device submissions. Includes pre-market documentation requirements, threat modeling guidance, and post-market monitoring essentials.
- • Latest FDA guidance alignment (2023)
- • Pre-market submission requirements
- • SBOM (Software Bill of Materials) guidance
- • Post-market monitoring framework
- • Risk assessment templates
10 MedTech Software Mistakes to Avoid
Learn from common pitfalls that derail medical device software projects. Based on our experience with dozens of FDA submissions and regulatory reviews.
- • Documentation gaps that cause delays
- • Cybersecurity oversights
- • Risk management blind spots
- • Validation and verification errors
- • Post-market compliance issues
Expert Articles & Best Practices
In-depth guidance from our team of medical device software experts
Why ISO 13485 Certification Matters for Software Development
Understanding the critical role of ISO 13485 in medical device software development and how it impacts your regulatory strategy and investor readiness.
Post-Market Cybersecurity Management Best Practices
Essential strategies for maintaining cybersecurity compliance after FDA clearance, including vulnerability management and incident response planning.
IEC 62304 Software Lifecycle Process Implementation
Practical guidance for implementing IEC 62304 software lifecycle processes in medical device development, with templates and examples.
Medical Device Risk Management with ISO 14971
Comprehensive guide to applying ISO 14971 risk management principles to medical device software development and cybersecurity.
AI in Medical Device Software: Regulatory Considerations
Navigate the evolving regulatory landscape for AI-powered medical devices, including FDA guidance and best practices for compliant AI implementation.
Tools & Templates
Ready-to-use resources to accelerate your compliance efforts
Risk Assessment Templates
Pre-built templates for conducting comprehensive risk assessments according to ISO 14971 standards, customized for medical device software.
Cybersecurity Documentation Package
Complete documentation templates for FDA cybersecurity submissions, including threat modeling worksheets and security architecture guides.
Software Validation Checklists
Comprehensive checklists for IEC 62304 software validation and verification activities, ensuring no critical steps are missed.
Post-Market Monitoring Framework
Structured framework for ongoing cybersecurity monitoring and incident response planning after FDA clearance.
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