In today’s rapidly evolving healthcare landscape, connected medical devices are increasingly vulnerable to cybersecurity threats. As these technologies become more integrated into clinical environments and patient care, the consequences of a cyberattack are no longer limited to data breaches—they now pose a direct threat to patient safety. The risks are real and growing: ransomware can lock out access to life-saving equipment, and unsecured software updates can introduce unknown vulnerabilities. Regulatory bodies and manufacturers alike are being forced to shift their focus from traditional safety paradigms to a broader risk lens that includes cyber resilience.
This timely webinar will provide medical device manufacturers with an in-depth understanding of the intersection between cybersecurity and patient safety. Our expert panel will examine emerging global regulatory expectations from FDA premarket guidance to EU MDR, as well as key standards such as IEC 81001-5-1, AAMI TIR57 and UL 2900-2-1, and how risk-based thinking is now essential across the product lifecycle. Attendees will gain clarity on how security is no longer just an IT responsibility but a critical design and engineering function.
Where this webinar stands apart is in how we bring these expectations to life. Rather than reciting compliance checklists, we’ll use two hypothetical connected medical devices—a wireless insulin pump and an implantable pacemaker—as illustrative examples. We’ll walk through how each device might evolve over time, with new features, connectivity, and system complexity introducing new risks. At each stage, we’ll highlight how the level of cybersecurity maturity could scale accordingly—offering non-prescriptive, risk-informed concepts and design considerations that help clarify what stronger cybersecurity might look like as device risk increases.
Whether you're navigating regulatory submissions, developing internal cybersecurity processes, or preparing for third-party evaluations, this session will help you contextualize risk, understand emerging expectations, and explore practical approaches to strengthen device security. Register today to gain insights from CSA Group’s cybersecurity experts and better understand why risk-based engineering decisions are central to aligning with regulatory expectations—while helping protect both your products and the patients who rely on them.
Key Learning Objectives
- Understand how cybersecurity threats to connected medical devices have become direct patient safety risks, prompting a shift in engineering priorities.
- Gain clarity on global regulatory expectations and supporting standards, including IEC 81001-5-1, UL 2900-2-1, AAMI TIR57, and guidance from the FDA and EU MDR.
- See how risk-based decisions scale with increasing product complexity through illustrative examples of evolving medical device functionality.
- Learn how CSA Group assesses cybersecurity readiness through training, gap analysis, and conformance evaluations—and how manufacturers can strengthen their submissions and supporting evidence.
