Medical Device Manufacturers: Automate Your TPLC Security Risk Management Process

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Your Medical Device TPLC Cybersecurity Risk Management Solution

SelectEvidence™ is a market-leading TPLC cybersecurity risk management solution for connected medical devices. Built with the latest in AI and automation technologies,  SelectEvidence™ continuously monitors device vulnerabilities and identifies the appropriate mitigations, while generating live regulatory reports.
SelectEvidence™ provides medical device manufacturers with an intelligent, automated and traceable approach to cybersecurity risk management. As of March 2023, medical device manufacturers must meet certain FDA cybersecurity requirements.  You can easily meet with these new requirements by integrating with SelectEvidence™.

Features and Benefits

medical device auto ingest sboms
Auto-Ingest SBOMs

Simple and automated ingestion
of every SBOM.

Vulnerability Detection

Intuitive dashboard identifies and showcases all potential vulnerabilities.

Mitigation Identification

Mitigations and security controls are suggested for all potential vulnerabilities.

medical device continual monitoring

Continuous Monitoring

Continuous SBOM scanning with alerts provided on a weekly basis.

Accelerated Analysis

Proprietary algorithms significantly enhance the entire risk assessment process.

Threat Modeling

Users can import threat models or build their own entirely in-platform.

Enterprise Dashboard

Complete oversight of your portfolio’s cybersecurity posture.

medical device enterprise level reporting

Live Reports

Reports such as 510(k), RMF and MDS2 are auto-compiled during assessment process.

Standards-Based

Built using standards that are in line with regulatory expectations.

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Premarket Cybersecurity Acceleration

Postmarket Cybersecurity Acceleration

Compliance

Meet EU and FDA Premarket Submission and Postmarket Management guidelines.

A Direct 1:1 Solution for New FDA Cybersecurity Requirements

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Our Onboarding Process

Nova Leah has developed a simple and clear-cut onboarding process.
  1. Book an obligation-free demo

  2. We align SelectEvidence™ to your specific needs and success criteria

  3. Our team takes care of the entire onboarding process

  4. Your platform comes to you fully loaded with all of your risk assessments in continuous monitoring mode

  1. Step one: Learn how to use the platform with a detailed product demo

  2. Step two: Start your free five-day evaluation mapped to your specific success criteria

  3. Step three: Integrate SelectEvidenceTM into your product development lifecycle and enjoy the benefits!

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About Nova Leah

Nova Leah is a world leader in the provision of cybersecurity risk management solutions for medical device manufacturers and healthcare providers.

Join our team: We Are Hiring!

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SelectEvaluate® for Manufacturers

SelectEvaluate® for Healthcare
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P: +353 42 93 43 0 33

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Technology Park, Dundalk, Co Louth, Ireland A91 XR61

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