Nova Leah specialise in cybersecurity risk management software solutions for the medical device and healthcare industry. Nova Leah is the first company to develop an intelligent security risk management solution for use by manufacturers, vendors and healthcare providers. We have developed a number of solutions to provide medical device manufacturers and healthcare delivery organisations with an automated framework to assist both stakeholders in establishing and maintaining confidence in the security assurance of medical devices throughout the lifetime of the device.
Products and services
SelectEvidence® is a collaborative expert systems which supports medical device manufacturers in designing, verifying and vertifying connected medical devices to meet FDA premarket and postmarket cybersecurity guidelines and industry security standards. It also assists healthcare providers in the selection, acquisition and risk management of medical devices on their healthcare IT networks. SelectEvidence® allows stakeholders to implement cybersecurity requirements for their devices using proven standards within a collaborative framework. SelectEvidence® is supported by state of the art repositories which continuously monitors for new potential vulnerabilities and controls to mitigate associated risks.
In 2014 40% of all US hospitals reported criminal attempts to access medical devices on their networks. Medical devices are seen as the weak-link that can be used to launch network-wide malware attack.
Through these recent events it has become apparent that medical devices are vulnerable and so FDA have set out new cybersecurity recommendations for manufacturers. This presents a challenge for manufacturers but with SelectEvidence®, the entire cybersecurity process is managed from requirements gathering right through to product retirement. SelectEvidence® is the first expert system that guides manufacturers in identifying potential vulnerabilities and implementing the right security controls to mitigate associated risk. Our proprietary databases allow medical device manufacturers cut regulatory compliance costs by 80% by guiding them in identifying and implementing the right security requirements. We have a market-ready product, the first of its kind, it’s been road-tested by major customers and fine-tuned based on their feedback. Our sales activities and pilot projects in the US have generated a very healthy pipeline and we’re hearing SelectEvidence wins the “buy versus build” argument in terms of cost and quality.
SelectEvidence automatically generates all required FDA regulatory documentation and the tool can also be integrated with a manufacturers’ existing systems.
• Accelerates the time to market
• Reduces development costs
• Reduces the likelihood of product recalls
SelectEvidence® has been developed over the last 5 years and our team is recognized as international experts in medical device cybersecurity.