Cybersecurity risk
assessment services
– Bronze Package

Nova Leah is now offering a hands-on risk assessment solution. Within our Bronze package, our team of industry experts perform a comprehensive cybersecurity risk assessment of your medical device. 
  • Short-term engagement.
  • Cybersecurity risk assessment.
  • Compile sBoM.
  • Regulatory documentation preparation.
  • MDS2 creation.
Find Out More

“A specialist in cybersecurity for medical devices”

“A specialist in cybersecurity for medical devices, its platform SelectEvidence® helps medical device providers to monitor defibrillators, pacemakers and insulin pumps connected to wireless networks, to ensure they are safe and can deal with potential threats.”


WIRED Magazine, Listing Europe’s 100 Hottest Startups 2019

Your expert cybersecurity risk assessment partner

Industry leading expertise

By choosing Nova Leah to carry out your cybersecurity risk assessment you are leveraging the skills and expertise of one of the most experienced medical device cybersecurity teams in the industry.  This also removes the need to hire FTEs.

Get products to market faster and more effectively

Our team of experts will assist you in performing risk analyses, risk evaluations and security control identification in line with regulatory expectations. We have the expertise and knowledge of the regulatory landscape to get your products to market quicker and maintain the security assurance of devices during postmarket

Meeting FDA guidelines

Our cybersecurity risk assessment process is backed by our in-house solution, SelectEvidence®. Using SelectEvidence® as an integral part of our cybersecurity risk assessment process will ensure that your
connected medical devices meet FDA premarket submission
and postmarket management guidelines.

Increase in-house efficiency

Carrying out device risk assessment in-house can be labour-intensive and resource heavy. By leveraging Nova Leah’s skills, expertise and technology you not only get device risk assessment done efficiently but free up staff to work on other projects.

SelectEvidence® license

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. A SelectEvidence® license is included as part of both the Silver and Gold packages. 


Technology Ireland Awards | Ibec
Emerging Company of the Year -2019

High Potential Exporter Award
Export Industry Awards  Winner 2019

KTI Impact Awards 2019
Spin-out Company Award Winner 2019

Step 1: Comprehensive review
One product, one time engagement

Our team performs a comprehensive review of your existing product security related documentation and discuss the project scope with relevant stakeholders.

Step 2: Outline project plan
Mapped to your own success criteria

We develop a plan that outlines the objectives and deliverables of the project. This includes performing the preliminary risk assessment. 

Step 3: Assessment and reporting
Efficient reporting process

Medical device cybersecurity risk assessing is at the core of what we do and with our expert system, SelectEvidence® we deliver a quality risk assessment within an efficient time-frame.

Request a callback

If you are interested in finding out more about our Bronze package including prices, time-frames and processes, please fill in the form below and one of our team will be in touch shortly.  

Cybersecurity risk assessment packages


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. 

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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.  

Learn More

Get in Touch with us today!

Get In Touch
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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For Manufacturers
For Healthcare Operators
Gold Service
Silver Service
Bronze Service


P: +353 42 93 43 0 33
Block 3, Finnabair Business &
Technology Park, Dundalk, Co Louth, Ireland A91 XR61

P: +1 617 314 7010
6th Floor, 399 Boylston Street,
Boston, MA 02116,
United States

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