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# Nova Leah

Medical Device Cybersecurity Risk Management

## Sitemaps

- [XML Sitemap](https://www.novaleah.com/sitemap.xml): Contains all public & indexable URLs for this website.

## Posts

- [Blog](https://www.novaleah.com/blog/)
- [The MDS2 Standard and Its Role in Medical Device Security](https://www.novaleah.com/understanding-mds2s-and-their-role-in-medical-device-cybersecurity/)
- [What is Cybersecurity Posture?](https://www.novaleah.com/what-is-cybersecurity-posture/)
- [New Cybersecurity Requirements for Medical Devices, Your Questions Answered ](https://www.novaleah.com/new-security-requirements-for-medical-cyber-devices-explained/)
- [Part 2 of 3: Adapting to New Cybersecurity Requirements for Medical Cyber Devices (+Free Webinar Sign-up)](https://www.novaleah.com/part-2-of-3-adapting-to-new-cybersecurity-requirements-for-medical-cyber-devices-free-webinar-sign-up/)
- [Part 3 of 3: Adapting to New Cybersecurity Requirements for Medical Cyber Devices (+Free Webinar Sign-up)](https://www.novaleah.com/part-3-of-3-adapting-to-new-cybersecurity-requirements-for-medical-cyber-devices-free-webinar-sign-up/)
- [Part 1 of 3: Adapting to New Cybersecurity Requirements for Medical Cyber Devices (+Free Webinar Sign-up)](https://www.novaleah.com/part-1-of-3-adapting-to-new-cybersecurity-requirements-for-medical-cyber-devices-free-webinar-sign-up/)
- [Nova Leah Announces the Launch of SelectEvaluate®](https://www.novaleah.com/nova-leah-announces-the-launch-of-selectevaluate/)
- [Medical Device Industry Update July 2023](https://www.novaleah.com/medical-device-industry-update-july-2023/)
- [New Security Requirements for Medical Cyber Devices. Is Your Business Ready?  ](https://www.novaleah.com/new-security-requirements-for-medical-cyber-devices-is-your-business-ready/)
- [Employee Spotlight: Q&A With Nova Leah's Engineering Manager, Richard Hastings](https://www.novaleah.com/employee-spotlight-qa-with-nova-leahs-engineering-manager-richard-hastings/)
- [Employee Spotlight: Q&A With Nova Leah’s Customer Success Manager, Catherine McEnroe ](https://www.novaleah.com/employee-spotlight-qa-with-nova-leahs-customer-success-manager-catherine-mcenroe/)
- [Premarket Risk Management for Medical Device Manufacturers – Then vs Now ](https://www.novaleah.com/premarket-risk-management-for-medical-device-manufacturers-then-vs-now/)
- [Legacy Medical Devices: Are Older Devices More Vulnerable?](https://www.novaleah.com/medical-device-cybersecurity-for-older-products/)
- [Download Our FREE 7-Step Premarket Risk Management Checklist](https://www.novaleah.com/download-our-7-step-premarket-risk-management-checklist/)
- [Medical Device Industry Update March 2023](https://www.novaleah.com/medical-device-industry-update-march-2023/)
- [Medical Device Cybersecurity Industry Update June 2022  ](https://www.novaleah.com/medical-device-cybersecurity-industry-update-june-2022/)
- [Medical Device Industry Update September 2022](https://www.novaleah.com/medical-device-industry-update-september-2022/)
- [Medical Device Industry Update October 2022](https://www.novaleah.com/medical-device-industry-update-october-2022/)
- [Medical Device Industry Update November 2022](https://www.novaleah.com/medical-device-industry-update-november-2022/)
- [Medical Device Industry Update December 2022](https://www.novaleah.com/medical-device-industry-update-december-2022/)
- [Medical Device Industry Update January 2023](https://www.novaleah.com/medical-device-industry-update-january-2023/)
- [Medical Device Industry Update February 2023](https://www.novaleah.com/medical-device-industry-update-february-2023/)
- [Cybersecurity Challenges Facing Today’s Medical Device Industry ](https://www.novaleah.com/cybersecurity-challenges-facing-todays-medical-device-industry/)
- [$1.7 Trillion Omnibus Spending Bill a Game Changer for Strengthening Medical Device Supply Chains  ](https://www.novaleah.com/1-7-trillion-omnibus-spending-bill-a-game-changer-for-strengthening-medical-device-supply-chains/)
- [Why SBOMs are the Future of Medical Device Security](https://www.novaleah.com/why-sboms-are-the-future-of-medical-device-security/)
- [US Senator Releases Policy Options Paper on Cybersecurity and Patient Safety ](https://www.novaleah.com/us-senator-releases-policy-options-paper-on-cybersecurity-and-patient-safety/)
- [Medical Device Security: A 3-Pronged Approach to Establishing Foundational Requirements](https://www.novaleah.com/medical-device-security-a-3-pronged-approach-to-establishing-foundational-requirements/)
- [An Introductory Guide to Threat Modeling from Nova Leah ](https://www.novaleah.com/an-introductory-guide-to-threat-modeling-from-nova-leah/)
- [What is a 510(k)? – Plus Cybersecurity Considerations](https://www.novaleah.com/what-is-a-510k-plus-cybersecurity-considerations/)
- [Nova Leah’s Ultimate SBOM Guide (Software Bill of Materials)](https://www.novaleah.com/nova-leahs-ultimate-sbom-guide-software-bill-of-materials/)
- [The Role of SBOMs in Medical Device Risk Management ](https://www.novaleah.com/the-role-of-sboms-in-medical-device-risk-management/)
- [An Introduction to SBOMs: A Nutrition Label For Software](https://www.novaleah.com/ntia-sboms-and-the-future-of-medical-device-cybersecurity/)
- [IMDRF Publishes Long-Awaited Draft Guidance Related to SBOMs and Medical Device Cybersecurity ](https://www.novaleah.com/imdrf-publishes-long-awaited-draft-guidance-related-to-sboms-and-medical-device-cybersecurity/)
- [Breaking Down SBOM Myths vs Facts](https://www.novaleah.com/breaking-down-sbom-myths-vs-facts/)
- [Critical Software Definition - As per Biden’s Cybersecurity EO](https://www.novaleah.com/nist-releases-definition-of-critical-software-as-per-bidens-cybersecurity-executive-order/) - Critical Software Definition - Joe Biden's Cybersecurity Executive Order What is considered critical software? In May 2021, US President Joe Biden issued an ‘Executive Order on Improving the Nation’s Cybersecurity’. We’ve provided a full breakdown of the Cybersecurity Executive Order and its impact here. As part of Biden's executive order, federal agencies are required to
- [FDA Publishes Draft Guidance on Medical Device Cybersecurity (Pre-Market) ](https://www.novaleah.com/fda-publishes-draft-guidance-on-medical-device-cybersecurity-pre-market/)
- [Nova Leah Spotlight: Introducing Our Marketing Lead, Roberta Beattie](https://www.novaleah.com/nova-leah-spotlight-our-marketing-lead-roberta-beattie/)
- [Protecting the Software Supply Chain With SBOMs ](https://www.novaleah.com/protecting-the-software-supply-chain-with-sboms/)
- [Cybersecurity Executive Order – Understanding The Global Impact](https://www.novaleah.com/understanding-the-impact-of-joe-bidens-cybersecurity-executive-order/)
- [Software Bill of Materials: The Most Frequently Asked Questions](https://www.novaleah.com/software-bill-of-materials-the-most-frequently-asked-questions/)
- [Medical Device Cybersecurity Draft Guidance Explainer Series Part 1 of 3 – Security Risk Management ](https://www.novaleah.com/medical-device-cybersecurity-draft-guidance-explainer-series-security-risk-management/)
- [Medical Device Cybersecurity Draft Guidance Explainer Series Part 2 of 3 – Security Architecture ](https://www.novaleah.com/medical-device-cybersecurity-draft-guidance-explainer-series-part-2-of-3-security-architecture/)
- [Without Transparency, Software Supply Chains Can Fall Apart at the Seams ](https://www.novaleah.com/without-transparency-software-supply-chains-can-fall-apart-at-the-seams/)
- [Nova Leah Spotlight: Q&A Session with Our Vice President of Sales, Joe Madden ](https://www.novaleah.com/nova-leah-spotlight-qa-session-with-our-vice-president-of-sales-joe-madden/)
- [Nova Leah Announces the Appointment of Two New Board Members  ](https://www.novaleah.com/nova-leah-announces-the-appointment-of-two-new-board-members/)
- [Press Release: Latest Nova Leah Investment News](https://www.novaleah.com/press-release-latest-nova-leah-investment-news/)
- [Medical Device Cybersecurity Draft Guidance Explainer Series Part 3 of 3 – Cybersecurity Testing](https://www.novaleah.com/medical-device-cybersecurity-draft-guidance-explainer-series-part-3-of-3-cybersecurity-testing/)
- [The Medical Device Regulation: Strengthening Cybersecurity for Medical Devices in the EU ](https://www.novaleah.com/the-medical-device-regulation-strengthening-cybersecurity-for-medical-devices-in-the-eu/)
- [SBOM - The Security Benefits of a Software Bill of Materials](https://www.novaleah.com/sbom-the-security-benefits-of-a-software-bill-of-materials/)
- [HSCA Releases Cybersecurity Guidelines to Help Protect Patient Health, Safety, And Privacy](https://www.novaleah.com/hsca-releases-cybersecurity-guidelines-to-help-protect-patient-health-safety-and-privacy/)
- [Rubric For Applying CVSS To Medical Devices](https://www.novaleah.com/rubric-for-applying-cvss-to-medical-devices/)
- [CIA Triad for Medical Devices – Strengthening Information Security](https://www.novaleah.com/the-cia-triad-of-cybersecurity-for-medical-devices/)
- [Nova Leah Wins Top Exporter Award](https://www.novaleah.com/nova-leah-wins-top-exporter-award/) - Nova Leah is delighted to have been selected as the ‘2019 High Potential Exporter of the Year’ at the Export Industry Awards. The award is recognition of the strong international growth that Nova Leah has enjoyed and a fantastic year for the company. When deciding the winner, a prestigious judging panel took into account a
- [Interview With Nova Leah Founder Anita Finnegan (Silicon Republic)](https://www.novaleah.com/interview-with-nova-leah-founder-anita-finnegan-silicon-republic/) - 2019 was an incredible year for us here at Nova Leah, one of numerous highlights. At the beginning of the year Nova Leah secured just under €4 million as part of the government’s Disruptive Technology Innovation Fund. This funding, along with continued market growth, helped us to expand our team and move to a brand
- [Living in Dundalk, Home of Nova Leah](https://www.novaleah.com/living-and-working-in-dundalk-home-of-nova-leah/) - Living in Dundalk, Home of Nova LeahAs one of the top medical device cybersecurity companies in the world, Nova Leah attracts some of the industry's brightest talent who are now living in Dundalk but making an impact worldwide. In this article, we are going to look at what it's like to live and work a
- [Biggest Challenge Facing the Connected Medical Device Industry](https://www.novaleah.com/biggest-challenge-facing-the-connected-medical-device/) - Executive Summary Connected medical device vulnerabilities continue to proliferate at an alarming rate. Hospital networks are consistently under attack posing a significant threat to patient safety, and medical device manufacturers arestruggling to implement cybersecurity risk management requirements using proven standardized and collaborative risk management frameworks. On the regulatory side, conducting a cybersecurity risk assessment is
- [Medical Device Cyber Threats Are Real And Ever Present – How To Implement Effective Security Risk Management](https://www.novaleah.com/medical-device-cyber-threats-are-real-and-ever-present-how-to-implement-effective-security-risk-management/) - Cybersecurity threats to connected medical devices are real, ever-present, and continuously changing according to the US Federal Drug Administration (FDA). Hospital networks are experiencing constant attempts of intrusion and attack posing a serious threat to patient safety.Increased connectivity of medical devices to hospital IT-networks provides significant benefits to patient care but also exposes both manufacturers,
- [Medical Device Cybersecurity Company Targets $50 Billion Global Connected Medical Device Market](https://www.novaleah.com/medical-device-cybersecurity-company-targets-50-billion-global-connected-medical-device-market/) - Lero researchers from the Regulated Research Centre at Dundalk Institute of Technology have launched a new medical device cybersecurity company that plans to create 78 jobs over the next four years. The Lero DkIT spinout company, Nova Leah (www.novaleah.com) has developed an expert cybersecurity risk management software application aimed at global medical device manufacturers and
- [Selectevidence®Provides The Medical Device Industry With The Only Expert Cybersecurity Risk Management Solution](https://www.novaleah.com/selectevidence-provides-the-medical-device-industry-with-the-only-expert-cybersecurity-risk-managment-solution/) - NOVA LEAH continues to set the standard for cybersecurity risk management solutions in the medical device industry The experts at Nova Leah have developed SelectEvidence® to address the industry drivers and challenges facing medical device manufactures today and in the future. SelectEvidence® is a turnkey collaborative cybersecurity expert system that supports medical device manufacturers in designing, verifying
- [Nova Leah's Key Takeaways From Black Hat and DEFCON 2019](https://www.novaleah.com/key-takeaways-2019-black-hat-defcon/) - Every August, thousands of cybersecurity professionals and top security minds descend upon Las Vegas to experience what has become one of the biggest weeks in the information security calendar. Dual conferences held back to back, Black Hat and DEFCON, provide a 360 view of today’s security landscape. Tackling the issue of internet security from opposing
- [Nova Leah Receives Certification for ISO 27001 and ISO 9001](https://www.novaleah.com/nova-leah-receives-certification-for-iso-27001-and-iso-9001/) - PRESS RELEASE: Nova Leah in Double Whammy for ISO Certification, Having Successfully Achieved ISO 27001 For Information Security Management and ISO 9001 for Quality Management [Boston, MA, Monday 23rd September, 2019] Nova Leah, a leading cybersecurity solutions provider for medical device manufacturers, announced this week that it has achieved certification to ISO 9001 in
- [Nova Leah's Key Takeaways From MedTech Boston](https://www.novaleah.com/nova-leahs-key-takeaways-from-medtech-boston/) - October is National Cybersecurity Awareness Month (NCSAM) in the United States. A collaborative effort between government and industry, this campaign aims to raise awareness about the importance of cybersecurity. This coincides with CyberSecMonth, the EU’s annual equivalent that builds awareness across Europe. Towards the end of September, before National Cybersecurity Awareness Month had begun, MedTech Boston Conference took place. During this three-day event, more than 3,300 of the world’s top MedTech executives gathered in Boston to discuss the latest news, insights, innovations and business development opportunities related to the medical device industry. Rather appropriately, a
- [Research, Landmark Achievements and the Future: An Interview with Fergal McCaffery](https://www.novaleah.com/interview-with-fergal-mccaffery/) - In September, Nova Leah Cofounder, Fergal McCaffery, was appointed the first Professor of Computer Science at Dundalk Institute of Technology and won the Lero President’s Award for Innovation and Entrepreneurship. Fergal is internationally recognised for his contributions to medical device software engineering. His research team has led the development of four International Standards/Technical reports for the global medical device software community. We
- [Nova Leah Shortlisted for Five Top Tech Awards](https://www.novaleah.com/nova-leah-shortlisted-for-five-top-tech-awards/) - PRESS RELEASE: Irish Cybersecurity Software Firm Nova Leah Shortlisted for Five Top Tech Awards [Dublin, Ireland, Oct 22 2019] Dundalk-based company, Nova Leah continues to stand out in the cybersecurity sector, with nominations for five awards across three different technology award events in Ireland. The medical device cybersecurity company, founded by award-winning female entrepreneur
- [Nova Leah Announces December 6th Event Speakers!](https://www.novaleah.com/nova-leah-announces-december-6th-event-speakers/)

## Pages

- [Home](https://www.novaleah.com/)
- [About](https://www.novaleah.com/about-us/)
- [New FDA Cybersecurity Requirements for Medical Devices](https://www.novaleah.com/new-fda-cybersecurity-requirements-for-medical-devices/)
- [SelectEvaluate For Healthcare Providers](https://www.novaleah.com/selectevaluate-for-healthcare-providers/)
- [SelectEvaluate – Customer Cybersecurity Risk Management](https://www.novaleah.com/customer-cybersecurity-risk-management/)
- [Careers](https://www.novaleah.com/careers/)
- [SelectEvidence – TPLC Security Risk Management](https://www.novaleah.com/selectevidence/)
- [SelectEvaluate MDM Case Study](https://www.novaleah.com/selectevaluate-mdm-case-study/)
- [SelectEvaluate HDO Case Study](https://www.novaleah.com/selectevaluate-hdo-case-study/)
- [Sign Up To SelectEvaluate Medical Device Manufacturers](https://www.novaleah.com/sign-up-to-selectevaluate/)
- [Demo (Main)](https://www.novaleah.com/demo/)
- [Sign Up To SelectEvaluate Healthcare Providers](https://www.novaleah.com/sign-up-to-selectevaluate-healthcare-providers/)
- [SelectEvaluate For Medical Device Manufacturers](https://www.novaleah.com/selectevaluate-for-medical-device-manufacturers/)
- [Software Terms and Conditions](https://www.novaleah.com/software-terms-and-conditions/)
- [Legal](https://www.novaleah.com/legal/)
- [Sign Our Software Terms and Conditions](https://www.novaleah.com/sign-our-software-terms-and-conditions/)
- [SelectEvaluate Demo](https://www.novaleah.com/selectevaluate-demo/)
- [Thank You For Signing Up to SelectEvaluate](https://www.novaleah.com/thank-you-for-signing-up-to-selectevaluate/)
- [Privacy Policy](https://www.novaleah.com/privacy-policy/)
- [Nova Leah Careers Marketing Manager](https://www.novaleah.com/nova-leah-careers-marketing-manager/)
- [Nova Leah Careers Sales Account Executive](https://www.novaleah.com/nova-leah-careers-sales-account-executive/)
- [Nova Leah Careers UX Designer](https://www.novaleah.com/nova-leah-careers-ux-designer/)
- [Nova Leah Careers Business Development Representative](https://www.novaleah.com/nova-leah-careers-business-development-representative/)
- [Nova Leah Careers VP Sales and Sales Operations](https://www.novaleah.com/nova-leah-careers-vp-sales-and-sales-operations/)
- [Manage my data](https://www.novaleah.com/manage-my-data/)
- [Nova Leah Careers Scrum Master](https://www.novaleah.com/nova-leah-careers-scrum-master/)
- [Thank You For Requesting Demo](https://www.novaleah.com/thank-you-for-requesting-demo/)
- [Solutions](https://www.novaleah.com/solutions/)
- [Thank You – Premarket Risk Management Checklist](https://www.novaleah.com/thank-you-premarket-checklist/)
- [Nova Leah Careers – Engineering Lead](https://www.novaleah.com/nova-leah-careers-engineering-lead/)
- [Contact](https://www.novaleah.com/contact-us/)
- [Thank You – Infosheet](https://www.novaleah.com/thank-you-infosheet/)
- [Nova Leah Careers – DevOps Engineer](https://www.novaleah.com/nova-leah-careers-devops-engineer/)
- [Nova Leah Careers DevOps / Cloud Engineer](https://www.novaleah.com/nova-leah-careers-devops-cloud-engineer/)
- [Nova Leah Careers Java Developer](https://www.novaleah.com/nova-leah-careers-java-developer/)
- [Nova Leah Careers QA Engineer](https://www.novaleah.com/nova-leah-careers-qa-engineer/)
- [Nova Leah Careers UX/UI Designer](https://www.novaleah.com/nova-leah-careers-ux-ui-designer/)
- [Nova Leah Careers Frontend Developer](https://www.novaleah.com/nova-leah-careers-frontend-developer/)
- [Team](https://www.novaleah.com/team/)
- [Nova Leah Careers Lead Development Representative](https://www.novaleah.com/nova-leah-careers-lead-development-representative/)
- [Thank You Newsletter](https://www.novaleah.com/thank-you-newsletter/)
- [Thank You Website Contact](https://www.novaleah.com/thank-you-website-contact/)
- [Thank You Services](https://www.novaleah.com/thank-you-services/)
- [Manage my data thankyou](https://www.novaleah.com/manage-my-data-thankyou/)
- [Nova Leah Careers Business Analyst](https://www.novaleah.com/nova-leah-careers-business-analyst/)

## Tatsu Global Sections

- [Footer](https://www.novaleah.com/tatsu_gsections/footer/)

## Categories

- [News](https://www.novaleah.com/category/blog/)
- [Medical Devices](https://www.novaleah.com/category/medical-devices/)
- [Medical Device Cybersecurity](https://www.novaleah.com/category/medical-device-cybersecurity/)
- [Risk Management](https://www.novaleah.com/category/risk-management/)
- [Cybersecurity Regulation](https://www.novaleah.com/category/cybersecurity-regulation/)
- [Cybersecurity Careers](https://www.novaleah.com/category/cybersecurity-careers/)
- [SBOMs](https://www.novaleah.com/category/sboms/)
- [Software Supply Chain](https://www.novaleah.com/category/software-supply-chain/)
- [Nova Leah Spotlight](https://www.novaleah.com/category/nova-leah-spotlight/)
- [Industry Update](https://www.novaleah.com/category/industry-update/)

## Tags

- [Executive order](https://www.novaleah.com/tag/executive-order/)
- [Joe Biden](https://www.novaleah.com/tag/joe-biden/)
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- [Cybersecurity for connected medical devices](https://www.novaleah.com/tag/cybersecurity-for-connected-medical-devices/)
- [Cybersecurity EO](https://www.novaleah.com/tag/cybersecurity-eo/)
- [Medical Devices](https://www.novaleah.com/tag/medical-devices/)
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