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AI Medical Devices: Answering Your Burning Questions
As artificial intelligence continues to revolutionize medical device development, the FDA’s evolving regulatory framework presents both...
Traditional CROs fragment device development with costly hand-offs and learning curves. Veranex unites the essential disciplines for medical device & diagnostic development under one roof from sketch to evidence-generation to market launch.
All connected. All aligned. All accelerating your path to market—delivering breakthrough devices and diagnostics that improve patient lives sooner.
Breakthrough innovation requires more than great solutions; it demands deep expertise and insight. Veranex packages outcome-driven solutions with 25+ years of specialized knowledge across major medtech categories, delivering integrated capabilities that solve your most pressing challenges faster and with greater certainty.
Purpose-built solutions. Proven results. User & Patient-centered innovation.
Whether you're transforming patient care or disrupting entire therapeutic categories, innovation requires more than great science, it demands velocity. Veranex was founded to bridge the gap between visionary concepts and market reality, combining proven expertise with agile execution to accelerate the innovations that matter most.
We are the Innovation CRO.
Legacy of excellence. Proven execution. Patient impact accelerated.
Beyond the Instrument
Point-of-care, at-home and central laboratory diagnostics instruments are part of a digital ecosystem that supports clinical workflows, caretakers, and patients. Touchpoints for these instruments often pose vulnerabilities that can be exploited by criminals, therefore requiring heightened security measures. APIs, wireless access, process automation software, and the use of third-party applications open up the system to a wide range of users with no or limited IT backgrounds. Users are concerned with getting their results with speed and are naturally focused on patient care rather than cyber security. Our approach generates an end-to-end solution that combines cyber security with robust software applications to support best-in-class user experience.
Mitigating Risk
Cyber security continues to make headlines in the news with major companies reporting ransomware attacks in which criminals encrypt important files and won’t unlock them until a substantial ransom is paid. Critical services like hospitals aren’t immune to these attacks. As recently as June 2024, a Russian cybercriminal group attacked pathology services at several British hospitals, disrupting more than 3,000 hospital and general practitioner appointments as well as risking the privacy of thousands of patients.
Diagnostics companies are working to increase the resilience of their instruments against these kinds of attacks and software needs to be continually updated to prevent external attacks that reach instruments (even small, point-of-care instrumentation) via the hospital’s software management system. Additionally, an attack on the software of diagnostics instruments distributed across the world would affect the lives of millions of patients.
Are you confident in your device’s ability to withstand security threats?
Veranex' cyber security solutions and experience for medical device and diagnostics instrument development projects means our team is up to date on professional standards, regulatory requirements and has the expertise to implement those security standards successfully; during development and in forward looking plans for the necessary monitoring of cyber security post-market release.
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As artificial intelligence continues to revolutionize medical device development, the FDA’s evolving regulatory framework presents both...
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