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arsMedSecurity
The Art of Medical Device Cybersecurity

We are a medical device cybersecurity consultancy.

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Our passion is assisting medical device manufacturers with bringing their medical devices to market and ensuring that they are secure.

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We are a new company with old roots. Our founder has been leading and working in medical device cybersecurity for over 20 years.

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We are different than most, we are NOT just Information Technology (IT) security engineers, only scoped to a TCP/IP connections, we are also medical device design engineers, and as such we understand and work with all of the Operational Technologies (OT) typically utilized in a medical device including Bluetooth Low Energy,  inductive, and MedRadio.

Services

  • 510k and SOP MS Word templates  

  • Gap Analysis

    • Project gap analysis (DHF review, including all security documentation and activities)  

    • QMS Gap Analysis (existing policies/procedures changes and what is missing)  

  • Project Specific Cybersecurity Assistance (i.e. 510(k) submission focused) 

    • Creation of all documents required for the cybersecurity section of the FDA's eSTAR system

    • All cybersecurity testing

      • Penetration​

      • Fuzz

      • Malformed User Inputs

      • SAST

      • Attack Surface Analysis

      • SBOM Monitoring

    • Review/response for FDA Hold letter 

  • Corporate Governance

    • Create missing policies and procedures 

    • SOP Alignment with secure development frameworks (IEC 81001-5-1 & NIST 800-218) 

    • SOP creation for Coordinated Vulnerability Disclosure and Incident Response 

  • Post-Market Cybersecurity Testing and Surveillance

    • As required per the FDA’s Sept. 2023 Premarket Guidance 

    • Periodic re-performance of cybersecurity testing 

    • SBOM monitoring 

    • Results are stored in a highly encrypted online folder for customer convenience 

  • General Cybersecurity Consulting

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