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
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
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;
