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.
“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.
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Emerging Company of the Year -2019
High Potential Exporter Award
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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.
