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Empower Your Medical Device Cybersecurity

Our Services

Medical Device Cybersecurity Solutions

arsMedSecurity offers comprehensive cybersecurity solutions for medical device manufacturers. Our team of experts assists in securing medical devices and ensures compliance with regulatory requirements. With a focus on robust security measures and documentation while containing costs.

Cybersecurity Activities

At arsMedSecurity, we provide tailored support for regulatory compliance. Our services cover the documentation and processes necessary for premarket regulatory approval. These include the creation of the following artifacts:

  • Risk Management Report

  • Threat Model Report

  • Cybersecurity Risk Assessment Report

  • Software Bill of Materials

  • SBOM Support Report

  • Software Component Safety and Security Assessment Report

  • Vulnerabilities with Uncontrolled Risk Report

  • Unresolved Anomalies Risk Management Report

  • Cybersecurity Metrics Report

  • Cybersecurity Controls Report

  • Architecture Views Report

  • Cybersecurity Testing Report

    • And all required cybersecurity tests​

  • Cybersecurity Labeling Report

  • Security Risk Management Plan

  • Interoperability Verification and Validation Report(s)

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Trusted Partners

Because we are engineers, we are used to working in development teams and working with the unique technologies and communications commonly found in medical device systems.

By leveraging our development and cybersecurity experience, we ensure that your medical device project will proceed with minimum issues and delays related to cybersecurity.

What Does Engagement Look Like?

At arsMedSecurity, we frequently find that our customers need a quick start and a rapid implementation of cybersecurity for a product under development.

We understand how this can happen, and we have a long history of fixing our client's problems in their compressed timescale.

Other Services

Beyond the usual fixed price medical device development cybersecurity services, we also offer:

  • Fractional vCPSO "Chief Product Security Officer" (includes post market security testing)

  • eSTAR 510(k) Templates in MS Word Format

  • Software and firmware design & development

  • Electronic hardware design & development

  • Regulatory assistance

 

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