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

Expert Articles & Best Practices

In-depth guidance from our team of medical device software experts

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.

Expert Guide • 12 min read

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.

Compliance Guide • 8 min read

Post-Market Cybersecurity Management Best Practices

Essential strategies for maintaining cybersecurity compliance after FDA clearance, including vulnerability management and incident response planning.

Best Practices • 10 min read

IEC 62304 Software Lifecycle Process Implementation

Practical guidance for implementing IEC 62304 software lifecycle processes in medical device development, with templates and examples.

Implementation Guide • 15 min read

Medical Device Risk Management with ISO 14971

Comprehensive guide to applying ISO 14971 risk management principles to medical device software development and cybersecurity.

Risk Management • 12 min read

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.

AI & Regulation • 14 min read

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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