Cybersecurity risk assessment services - Gold package

Our most complete risk assessment package. After our team carry out the initial cybersecurity risk assessment, you are set up on our award-winning platform, SelectEvidence®. We then provide ongoing technical and expert consultative support. 

  • Cybersecurity risk assessment.
  • All features included in the Silver and Bronze packages.
  • Ongoing tech support.
  • SelectEvidence® license.
  • Monthly risk assessment consultations.

“A specialist in cybersecurity for medical devices"

5/5
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“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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Technology Ireland Awards | Ibec
Emerging Company of the Year -2019

Awards

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High Potential Exporter Award
Export Industry Awards  Winner 2019

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KTI Impact Awards 2019
Spin-out Company Award Winner 2019

Step 1: Comprehensive review

Initial engagement

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

Step 2: Full risk assessment

Expert support and licensing

The team at Nova Leah perform a full risk assessment in line with TIR57 and ISO 14971. You are then given a full SelectEvidence® license along with ongoing tech support.

Step 3: Ongoing consultation

Monthly risk assessment support

Included in the Gold package are ongoing cybersecurity risk assessment consultations held monthly. This is a cradle to grave solution combining technology and services.

Request a callback.

If you are interested in finding out more about our Gold 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

Bronze

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. 

Silver

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. 

Gold 

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.  

Leadership team

Anita Finnegan
CEO/Founder

Anita founded Nova Leah and is the Author and International Project Leader of IEC 80001-2-8 and IEC 80001-2-9. As an ...internationally recognized expert in Medical Device Cybersecurity she also has a strong background in software quality processes, engineering and quality engineering roles across multiple highly regulated domains. Anita's PhD research focused on medical device cybersecurity assurance cases.

Peter Finnegan
Co-Founder

Peter brings over 30 years’ experience in the global healthcare and pharmaceutical business to Nova Leah. Peters expertise ...culminated over 28 years of senior management leadership.

Fergal McCaffery
Co-founder / Head of Engineering

Fergal is internationally recognized for his contributions to medical device software engineering. His research team ...have led the development of 4 International Standards/Technical reports for medical device software. He was also the Leader for the development of IEC/TR 80002-3 for medical device software processes in collaboration with the ISO/IEC 62304 development team. Fergal is also Senior Lecturer in the Department of Computing and Mathematics, in Dundalk Institute of Technology (DkIT).