Nova Leah

World-leading cybersecurity solutions for medical device manufacturers and healthcare providers.

Our Vision

We seek to combine our expertise and skillsets to develop industry leading technology solutions that provide the necessary knowledge and guidance your workforce needs to develop and maintain more secure medical devices in a continuous fashion.

Our Solution

Medical device manufacturers face three challenges: 1/ The overwhelming lack of cybersecurity expertise in the domain 2/ The need to minimise the probability of malicious attacks to medical devices 3/ Ensuring compliance with ever-evolving cybersecurity regulations.

Nova Leah’s SelectEvidence® was designed to overcome all three challenges. SelectEvidence®, Nova Leah’s flagship product, is a user-friendly expert SaaS system that accurately tracks risks for each device by the development and monitoring of a software Bill of Materials (sBoM). SelectEvidence© identifies vulnerabilities specific to each device, recommends solutions, provides a feedback mechanism between manufacturers and healthcare providers and does so within a fully traceable framework.

Our Expertise

Nova Leah is made up of some of the industry’s most well respected cybersecurity risk management experts, engineers, and developers. Our incredible team has contributed enormously to our success to date, helping us win multiple awards for innovation, security and technological impact​.

Our Leadership

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).

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).

Michelle Jump
V.P. of Cyber Program Initiatives

Michelle has over 18 years of experience bringing technology-based solutions to healthcare, actively participating  ...in a variety of domestic and international standards, as well as relevant industry and governmental initiatives to support medical device security within the healthcare industry. Her specialty is in the integration of product security programs into medical device quality systems.

Christian Dunster
V.P. of Customer Success & Sales Operations

Chris brings over 20 years of client service operations, sales operations, product management, marketing research, ...and finance expertise to Nova Leah. Prior to joining Nova Leah, Chris was Vice President of Global Panel Operations at Lightspeed, LLC (now Kantar) where he oversaw the world’s largest collection of actively managed consumer market research panels. Previous leadership roles at start-up and mid-size ventures resulted in three successful equity events.

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

Awards

iea-award-logow
High Potential Exporter Award
Export Industry Awards  Winner 2019

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KTI Impact Awards 2019
Spin-out Company Award Winner 2019

Highlights and Awards

High Potential Exporter Award
Export Industry Awards 2019 Winners Nova Leah wins High Potential Exporter Award at the 2019 Irish Exporters Association supported by Enterprise Ireland.
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 | KTI Impact Awards 2019

KTI Impact Awards 2019
Spin-out Company Award 2019 Winner Knowledge Transfer Ireland recognised research that is benefiting the Irish economy and society at last night’s Impact Awards.
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Technology Ireland Awards in association with Ibec
Emerging Company of the Year - Winner 29 entries from companies and organisations have been shortlisted for the Technology Ireland Software Industry Awards 2019. Technology Ireland, alongside award platinum sponsors...
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 | Crunchbase’s 50 Female Entrepreneurs Everyone Should Know

Crunchbase’s 50 Female Entrepreneurs Everyone Should Know
Crunchbase's 50 Female Entrepreneurs Everyone Should Know Anita Finnegan, CEO & Founder Of Nova Leah. Investor include: Kernel Capital, COSIMO Ventures Nova Leah develops cybersecurity risk assessment solutions for connected...
Read More
 |  10 promising European start-ups founded by strong woman

 10 promising European start-ups founded by strong woman
10 promising European start-ups founded by strong woman Though the numbers show that only European 12% of startups that raise VC funding are founded by women, versus 88% for men, companies...
Read More
 |  15 trailblazing entrepreneurs to watch in 2019

 15 trailblazing entrepreneurs to watch in 2019
15 trailblazing entrepreneurs to watch in 2019 From promising new start-ups to billion-dollar ideas going global, here are the entrepreneurs skyrocketing to success in 2019.
Read More
 | Bank of Ireland

Bank of Ireland
Bank of Ireland   Crunchbase's 50 Female Entrepreneurs Everyone Should Know Anita Finnegan, CEO & Founder Of Nova Leah. Investor include: Kernel Capital, COSIMO Ventures Nova Leah develops cybersecurity risk...
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Bank of Ireland
BOI Best Emerging Tech Nova Leah wins Grand Prix Award at the 2018 National Startup Awards powered by Bank of Ireland and Enterprise Ireland.
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 |  Top 13 Start-ups in Ireland – think Business

 Top 13 Start-ups in Ireland – think Business
Top 13 Start-ups in Ireland - think Business The winners at the 2018 National Startup Awards, powered by Bank of Ireland and Enterprise Ireland, represent some of the best new...
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 | Irish Small Business

Irish Small Business
Irish Small Business One of Ireland's hottest start-ups is to be honored at the Irish Small Business Awards in Philadelphia on 18 May. The news comes as the first 25 honorees on...
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 InterTradeIreland Seedcorn Regional Winner
InterTradeIreland Seedcorn Regional Winner The Finals of the All-Island Seedcorn Investor Readiness Competition 2017, the island’s biggest business competition for new start and early stage companies in any sector, from...
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 Sodexo Women Mean Business Newcomer Award – runner up
Sodexo Women Mean Business Newcomer Award - runner up We are delighted to announce the 2017 finalists for the WMB Awards. As always the standard was incredibly high and the...
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 | Nova Leah start-up of the week – SiliconRepublic

Nova Leah start-up of the week – SiliconRepublic
Nova Leah start-up of the week - SiliconRepublic Our start-up of the week is Nova Leah, which has developed an expert cybersecurity system for medical devices.
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SelectEvidence - Complete Cybersecurity Management

SelectEvidence® provides manufacturers with an intelligent, standardized, repeatable and traceable approach to implementing cybersecurity requirements across for connected medical devices. SelectEvidence enables medical device manufacturers to:
  • Fulfill FDA (or EMA) requirements;
  • Streamline FDA (or EMA) 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;

Board and Advisors

Anita Finnegan
Nova Leah

Peter Finnegan
Nova Leah

Fergal McCaffery
Nova Leah

Jayne Brady
Kernel Capital

Barry Downes
Sure Valley Ventures

The medical device cybersecurity compliance and risk management experts