Nova Leah is a world leader in the provision of cybersecurity solutions for medical device manufacturers and healthcare providers. Headquartered in Ireland and with a presence in Boston, Nova Leah’s software helps connected medical device manufacturers meet cybersecurity compliance requirements throughout the entire product lifecycle.
SelectEvidence®, Nova Leah’s flagship product, is an expert cybersecurity risk assessment platform that automates the entire product cybersecurity assessment for new product development (premarket) and legal products (postmarket). Manufacturers upload a Software Bill of Materials (sBoM) and the automated risk assessment begins by identifying associated vulnerabilities and highlighting key mitigating security controls. The continuous process is managed in a completely traceable manor which automatically generates all compliance documentation in real time. SelectEvidence® provides one central hub to provide visibility of an organisations cybersecurity posture across an entire product portfolio.
Medical devices are becoming more and more connected to IT networks and to wireless networks. While this provides many benefits to the healthcare systems and patients, it is known that millions, if not all of these devices are vulnerable and open to cybersecurity attacks. With this is mind many governments and regulatory bodies have set out stringent cybersecurity requirements for medical device manufacturers. Nova Leah’s software platform, SelectEvidence uses AI and ML to automate the process of conducting a cybersecurity assessment during development and throughout the entire lifecycle of a medical device by monitoring for new vulnerabilities and instantly alerting manufacturers to this…all while meeting regulatory expectations.
Nova Leah is an ISO 9001 and ISO 27001 certified organisation.
Diagnostics; Digital Health; Healthcare; Life Sciences; Med Devices; Medical Sub-Supply; Medtech; Wearable Technologies
Medtronic, BioMerieux, Varian Medical Systems
Underwriter Laboratories (UL), Mayo Clinic
North America and EU