Nova Leah

Nova Leah is a medical device cybersecurity compliance company founded in 2015 in Dundalk, Ireland, spinning out of the Regulated Software Research Centre at Dundalk Institute of Technology, part of the Lero software research network. Co-founded by Peter Finnegan, Anita Finnegan, and Fergal McCaffery, the company focuses narrowly on a real regulatory pain point: medical device manufacturers must produce extensive, auditable cybersecurity risk documentation to get FDA and equivalent international market clearance, and again on an ongoing post-market basis, and most manufacturers were doing this manually in spreadsheets and word processors.

Nova Leah’s SelectEvidence product orchestrates cybersecurity risk assessments throughout a medical device’s development lifecycle and automatically generates the structured documentation the FDA expects for premarket submissions and post-market vulnerability reporting. A second product, SelectEvaluate, extends similar continuous-compliance tracking to third-party and connected-technology risk. The company has grown from an Enterprise Ireland-backed startup, raising a modest seed round in 2018, into a business with roughly 30 employees split between its Dundalk headquarters and a Boston, Massachusetts office aimed at the large U.S. medical device manufacturing market.

Nova Leah occupies a genuinely underserved niche — medical device cybersecurity compliance software specifically, rather than general GRC — and its growth from an academic spinout into a company with a real U.S. office and medical-device manufacturer customers is a credible signal. It remains a small company competing against both larger GRC platforms adding healthcare modules and manual, consulting-based alternatives, and independent verification of specific customer outcomes beyond company-published materials is limited.