Your expert cybersecurity risk assessment partner
Industry leading expertise
By choosing Nova Leah to carry out your cybersecurity risk assessment you are leveraging the skills and expertise of one of the most experienced medical device cybersecurity teams in the industry. This also removes the need to hire FTEs.
Get products to market faster and more effectively
Our team of experts will assist you in performing risk analyses, risk evaluations and security control identification in line with regulatory expectations. We have the expertise and knowledge of the regulatory landscape to get your products to market quicker and maintain the security assurance of devices during postmarket
Meeting FDA guidelines
Our cybersecurity risk assessment process is backed by our in-house solution, SelectEvidence®. Using SelectEvidence® as an integral part of our cybersecurity risk assessment process will ensure that your
connected medical devices meet FDA premarket submission
and postmarket management guidelines.
Increase in-house efficiency
Carrying out device risk assessment in-house can be labour-intensive and resource heavy. By leveraging Nova Leah’s skills, expertise and technology you not only get device risk assessment done efficiently but free up staff to work on other projects.
SelectEvidence® is an expert cybersecurity risk assessment platform that guides medical device manufacturers through the processes of identifying applicable threats to their products and implementing the right security controls to mitigate those threats. A SelectEvidence® license is included as part of both the Silver and Gold packages.