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Developed by medical device industry experts with decades of experience in cybersecurity risk management and threat handling. Our risk management platforms are preferred by leading medical device manufacturers and the world’s best hospitals. 

SelectEvidence®

SelectEvidence® is an expert cybersecurity risk assessment platform that guides medical device manufacturers through the processes of identifying applicable threats to their products and implementing the right security controls to mitigate those threats. It provides manufacturers with an intelligent, standardized, repeatable and traceable approach to implementing cybersecurity requirements across all connected medical devices. 
ACCELERATED ANALYSIS
 Proprietary algorithms inform accelerated analysis, greatly cutting the time needed to manage risk.
DECISION SUPPORT
 For every vulnerability identified, specific and actionable suggested mitigations are provided.
CONTINUOUS MONITORING AND ALERTS
Scanning over 180K vulnerabilities in real time, harnessing automation for 24/7 peace of mind.
Auto-ingest SBOMS
Simple and automated ingestion of each SBOM makes it easy and fast to start monitoring and managing risk.
STANDARDS BASED
 Linked to industry standards, leverage key repositories for controls threats and vulnerabilities.
ENTERPRISE LEVEL REPORTING
Multi-level access and reporting available for compliance transparancy and visibility.

The connected device challenge

  1. FDA/EU guidance requires rigorous attention to security throughout the entire product life cycle. Detailed care is needed at every single stage, from design consideration through to premarket submission, and then to postmarket management of cybersecurity in medical devices.
  2. Healthcare providers are seeking more information about their connected devices than ever before. The frequency and complexity of these inquries continue to impact the manufacturer sales cycle. Security, now more than ever, is a significant factor in the procurement decision. 
  3. Assessment of risk is labor-intensive, expensive and complicated. Often reliant on spreadsheets, non-standardized methods are limited to single snapshots in time. As the threat landscape is continuously evolving, the process of monitoring, identifying and mitigating threats becomes unmanageable. 
  4. Patient safety is of critical importance. Maintaining and assuring patient safety also has a direct impact on manufacturer reputation and sales performance.

Nova Leah’s industry experts have developed a world-class solution for these challenges; a centralized platform for continuous, automated, real-time cybersecurity risk management.

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The SelectEvidence® Solution

Benefits of SelectEvidence®

Leveraging SelectEvidence® as an integral part of your product development life cycle for security risk assessment will assure that your connected medical devices meet FDA/EU Pre-market Submission and Post-market Management guidelines.
In addition, SelectEvidence® performs ongoing vulnerability monitoring ensuring any potential vulnerabilities are being identified proactively. As soon as SelectEvidence® identifies potential vulnerabilities, an email notification is sent to your development and support teams immediately. This affords you the opportunity to respond to and mitigate potential risks in a timely manner.
THE BOTTOM LINE

Our solutions enable you to:

  • Fulfill FDA/EU requirements;

  • Streamline FDA/EU market approvals and assessments;

  • Reduce the cost to develop a product;

  • Reduce the time-to-market for devices;

  • Prevent the likelihood of recalls due to cybersecurity vulnerabilities;

  • Ensure compliance with standards, best practice and future legislation;

  • Provide documentary evidence of compliance to regulators, auditors and customers.

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About Nova Leah

Nova Leah is a world leader in centralized risk management systems. Our solutions, designed by industry experts, provide complete oversight of medical device vulnerabilities and threats, and automate the management and mitigation of risk.

Join our team: We Are Hiring!

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