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What We Do Advisory Services Cybersecurity

Cybersecurity

Your MedTech Champion for Secure Device Development and FDA Submission Success

Medical device cybersecurity is now a core regulatory expectation. FDA, EU MDR/IVDR, and global authorities enforce cybersecurity requirements with growing rigor, affecting SaMD/AI, wearables, connected diagnostics, implantables, and any device with software or connectivity. Avania unifies 25+ years of FDA regulatory experience with deep engineering and EU cybersecurity expertise to help teams address these expectations without slowing development.

We integrate Secure by Design principles from concept through post-market use, ensuring cybersecurity strengthens patient safety, supports clinical workflows, and accelerates regulatory approval.

Key Differentiators:

  • We facilitate hardware, firmware, and embedded systems engineering with IEC 60601 testing
  • Cybersecurity integrated within design controls rather than added before submission
  • Full FDA submission support, from cybersecurity documentation through clinical evidence
  • Post-market vulnerability monitoring and SBOM lifecycle management
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Navigating the FDA Cybersecurity Maze

FDA’s current guidance defines “cyber devices” broadly. Any product with software or connectivity — USB, Bluetooth, Wi-Fi, or wireless interfaces — must meet Section 524B requirements, including threat modeling, machine-readable SBOMs, architecture documentation, and post-market vulnerability monitoring.

A single vulnerability can halt development. FDA hold letters can delay market entry by six to twelve months. EU Notified Body non-conformances can pause CE marking. Post-market cybersecurity incidents risk recalls, enforcement actions, and reputational damage.

The investment required to build cybersecurity correctly is significant, yet the cost of failure — lost time, lost trust, and lost market share — is far greater.

Why a Specialized FDA Cybersecurity Partner?

Cybersecurity failures in MedTech have consequences beyond compliance. They threaten patient safety, device reliability, and commercial viability. Regulatory expectations continue to evolve, and generic cybersecurity consultancies rarely understand the nuances of FDA guidance, clinical workflows, or the constraints of medical hardware and embedded systems.

Avania’s cybersecurity model is tailored specifically to device development. We translate guidance into actionable requirements, link security decisions to device architecture, and support the full regulatory narrative from threat modeling through submission.

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Cybersecurity: Integrated from Day One

Couple Avania’s FDA Cybersecurity Expertise + Global Design Lab Software Development Teams

Cybersecurity decisions influence — and depend on — system architecture, hardware interfaces, software lifecycle controls, and update mechanisms. Avania integrates these domains rather than treating cybersecurity as a silo.

Our teams provide:

  • Penetration testing geared for your development team
  • Embedded systems and software development with Secure by Design processes
  • Regulatory alignment across cybersecurity documentation, design controls, and DHF
  • Support at any stage: early threat modeling, pre-submission documentation, or hold letter remediation

This integration ensures cybersecurity reflects how the device is actually built.

IVD development touches design controls, clinical evidence, software validation, quality systems, and market access. Avania integrates these disciplines so you’re not managing multiple vendors working from different assumptions.

Our Global Design Lab supports hardware and firmware development; our SaMD team addresses diagnostic software; our clinical operations group executes performance studies. Engage us at any point and gain guidance informed by what comes next.

Abstract glitter particles in dark space

Why Medical Devices Need an FDA-First Cybersecurity Approach

Traditional cybersecurity firms focus on networks, not devices. They rarely understand FDA SBOM formats, MDR guidance, or clinical exceptions such as emergency access for implantables.

Avania’s heritage is medical devices. We understand embedded systems, wireless protocols, hardware constraints, and regulatory evidence requirements. When penetration testing identifies vulnerabilities, our teams implement comprehensive mitigations rather than relying solely on software patches. When EU MDR expectations must align with FDA security architecture views, we reconcile both to create a unified, defensible submission.

Two surgeons working and passing surgical equipment in the operating room

Cybersecurity with Global Reach

Most cybersecurity partners work within a single regulatory framework. Avania prepares cybersecurity documentation for FDA and EU authorities simultaneously.

Where requirements align, such as threat modeling, risk-based controls, secure development, testing, and post-market vigilance, we build unified programs. Where they diverge, including FDA’s emphasis on SBOM formats and coordinated disclosure compared with the EU’s state-of-the-art justification, we navigate those differences efficiently without duplicating effort.

IT Specialist Concentrating on Data and Programming in a Dark, Tech-Driven Workspace

Comprehensive FDA Cybersecurity Capabilities

  • System-level threat modeling
  • Security architecture aligned with hardware interfaces, connectivity, and clinical use
  • Requirements compliant with IEC 62443-4-1, IEC 81001-5-1, and FDA Secure Product Development Framework expectations
  • Threat modeling per MITRE/MDIC with STRIDE analysis
  • FDA four-view security architecture documentation
  • Machine-readable SBOM generation
  • Cybersecurity risk assessments (AAMI TIR57)
  • Vulnerability monitoring and coordinated disclosure plans
  • FDA and EU documentation prepared in parallel
  • Secure boot and code signing
  • Cryptographic key management and hardware security modules
  • Secure firmware update mechanisms
  • Physical security controls
  • IEC 60601 testing relevant to cybersecurity
  • Penetration testing across network, application, and physical attack surfaces
  • Fuzz testing, static and dynamic code analysis
  • Security verification linked to threat models
  • Engineering remediation support
  • SBOM lifecycle management with NIST and CISA monitoring
  • Coordinated vulnerability disclosure processes
  • Security patch guidance
  • Incident response planning aligned to FDA and EU vigilance requirements

Our Experts

Cybersecurity Leadership with Engineering Depth

Avania’s experts unite engineering depth with frontline FDA and EU regulatory experience, giving your program guidance grounded in real device design and the latest cybersecurity expectations.

Nicholas Butt

Consultant, Cybersecurity Specialist

Nicholas Butt

  • Leads cybersecurity and software security integration for connected devices, SaMD, and AI/ML-enabled technologies
  • Strong record of FDA-accepted cybersecurity documentation, PCCPs, and SBOM lifecycle management
  • Experienced in threat modeling, IEC 81001-5-1 compliance, and secure software development for digital health
  • Directs medical device usability engineering (UE) and human factors (HFE) programs, including use-related risk analysis (URRA), formative and summative evaluations per IEC 62366-1 and FDA human factors guidance
  • Conducts penetration testing and vulnerability assessment for connected devices, including fuzz testing, SAST/DAST, SBOM analysis, and OWASP-aligned security validation
Acacia Parks

VP, Regulatory Compliance

Acacia Parks, PhD, MBA, RAC

  • Expert in digital health strategy, SaMD classification, cybersecurity frameworks, and AI/ML regulatory programs
  • Former CSO for multiple successful digital health companies with FDA-authorized SaMD products
  • Leads Avania’s Global Digital Health & AI/ML Center of Excellence
  • Bridges regulatory, clinical, and software strategy across FDA, EU MDR, and EU AI Act
  • Published author and invited speaker on digital health regulatory strategy, including the International Comparative Legal Guides (ICLG) Digital Health 2026
Samuel Engelman

Director, Regulatory

Sam Engelman

  • 15+ years of Global Regulatory program leadership, and prior regulatory leader at Cook Medical
  • Global strategist for FDA and experience with China NMPA CMDE medical devices center
  • ISO 13485 and Cybersecurity expertise
  • Specialized expertise in electrically active devices

Our Approach

Avania’s Integrated Approach to IVD Excellence

Strategic
Partnership

Direct access to engineers, developers, and regulatory experts working together on your project. When vulnerabilities appear, we resolve them — we don’t simply document them.

Purpose-Built Expertise

Threat models reflect real device architecture. Security controls align with hardware constraints. FDA submissions maintain a coherent, evidence-based narrative.

Flexible
Engagement

Full secure-product-development programs, targeted gap remediation, or embedded support. Start narrow or expand as your program evolves.

Operational Excellence

Quality systems aligned with IEC 62304, IEC 81001-5-1, and ISO 14971. Cybersecurity documentation integrates seamlessly with DHFs and technical files.


Ready to Secure Your Device for FDA and Global

Submission?

Connect with Avania’s cybersecurity and SaMD experts to review your program, identify gaps, and define a clear path to compliance and approval.

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