Centralized cybersecurity risk management
The medical device cybersecurity compliance and risk management experts
Continuous vulnerability monitoring
sBoM monitoring
MDS2 documentation
Standards-based platform
Regulatory submission documentation
Traceability, FDA 21 CFR Part 11.10 compliant
Transparency across your organization
Decision support
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What We Do

Nova Leah helps connected medical device manufacturers meet cybersecurity compliance requirements throughout the entire product lifecycle.

Why We Do It

Connected medical devices are increasingly vulnerable to cybersecurity risks, and the regulatory compliance landscape is complex and constantly evolving.

We’re passionate about providing medical device manufacturers with automated cradle-to-grave solutions for implementing and maintaining a strong cybersecurity posture across entire medical device product portfolios.

Our vision is to combine our expertise and technology to develop efficient solutions for the medical device industry, while providing the necessary processes and knowledge our customers require to develop and maintain more secure products.

Cybersecurity risk assessment packages


One time assessment report

Our team of experts will assist in performing risk analyses, risk evaluations and security control identification in line with regulatory expectations. This is a short-term engagement, typically one-time assessment of one product. 


Risk assessment setup and handover

Our team take you through the initial cybersecurity risk assessment process before setting you up with a SelectEvidence® license. Package includes one-time risk assessment and ongoing monitoring via the SelectEvidence® platform. 


Ongoing risk assessment support

Once initial risk assessment is carried out and your team is set up with SelectEvidence®, we remain on board as a dedicated partner.  This includes monthly consultations and ongoing support with your risk assessment activities.  


To deliver on that vision, we’ve developed SelectEvidence®, a first of its kind technology solution that is built to meet the latest regulatory standards.

Our expert software allows medical device manufacturers to quickly automate the process of identifying and mitigating potential vulnerabilities within their product portfolios, thus satisfying evolving regulatory needs.

Why Nova Leah

We’re dedicated to making medical device cybersecurity risk management as efficient and cost effective as possible for our customers.

Our team of internationally recognized cybersecurity risk management experts have decades of experience working for and with manufacturers. We volunteer our time for the betterment of the industry and have a first-hand appreciation of the challenge’s manufactures are facing today.

SelectEvidence®, our expert software solution helps small manufacturers establish the necessary cybersecurity risk management programs that are required to meet regulatory compliance, while also enabling large multi-national device manufacturers seeking to achieve global centralization and efficiency from their current programs.

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The medical device cybersecurity compliance and risk management experts