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Cybersecurity
Secure Products. Simpler Compliance.
Cybersecurity is now a critical part of medical device development and regulatory approval.
Genesys helps manufacturers integrate cybersecurity throughout product design, risk management and regulatory submissions.
Cybersecurity should be considered from the earliest stages of product development, not added after a product has been designed.
Our services include:
1. Regulatory Compliance
Support for FDA cybersecurity guidance, eSTAR submissions and industry standards.
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FDA eSTAR readiness
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IEC 81001-5-1
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IEC 62443
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AAMI TIR57
2. Risk Management
Identify, assess and mitigate cybersecurity risks early in development.
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Threat modelling (STRIDE)
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Cybersecurity risk assessments
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ISO 14971 integration
3. Secure Product Development
Build security into your product from the beginning.
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Secure architecture
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Authentication
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Encryption
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Embedded software security
4. Verification & Documentation
Prepare evidence for regulatory submissions.
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Security testing
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Cybersecurity reports
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Management plans
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Architecture documentation
Experience
Genesys has supported cybersecurity activities for connected medical devices and healthcare software, including:
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FDA eSTAR readiness
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STRIDE threat modelling
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Cybersecurity risk management
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Security architecture reviews
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Verification activities
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Postmarket planning
Why Genesys
✓ Experience supporting FDA cybersecurity activities
✓ Integrated electronics, embedded software and cloud expertise
✓ Cybersecurity aligned with medical device development
✓ Practical engineering solutions for regulated products
Preparing your next Connected Medical Device?
Talk to our engineering team about integrating cybersecurity into your product development process.
"Let's build something extraordinary together"