FDA's 2025 Cybersecurity Guidance for Medical Devices: What You Need to Know

🔐 𝗖𝘆𝗯𝗲𝗿𝘀𝗲𝗰𝘂𝗿𝗶𝘁𝘆 & 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗦𝗼𝗳𝘁𝘄𝗮𝗿𝗲: 𝗪𝗵𝗮𝘁 𝗬𝗼𝘂 𝗡𝗲𝗲𝗱 𝘁𝗼 𝗞𝗻𝗼𝘄 As medical software becomes increasingly connected, ensuring robust cybersecurity is no longer optional — it's 𝗲𝘀𝘀𝗲𝗻𝘁𝗶𝗮𝗹. In our latest blog, we explore how two important standards — IEC 81001-5-1 and IEC TR 60601-4-5 — are shaping the future of 𝗰𝘆𝗯𝗲𝗿𝘀𝗲𝗰𝘂𝗿𝗲 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁. From embedding security into the 𝘀𝗼𝗳𝘁𝘄𝗮𝗿𝗲 𝗹𝗶𝗳𝗲𝗰𝘆𝗰𝗹𝗲 to understanding risk-based approaches, the post outlines how aligning with these standards supports compliance, patient safety, and operational integrity. 📖 𝗥𝗲𝗮𝗱 𝘁𝗵𝗲 𝗳𝘂𝗹𝗹 𝗽𝗼𝘀𝘁 and stay ahead in secure MedTech innovation. 🔗 https://lnkd.in/dnc6FvtJ 👉 Let us know how your team is approaching software cybersecurity in the comments or reach out directly to start the conversation. #CyberSecurity #MedicalSoftware #IEC81001 #HealthcareInnovation #DmedSoftware

In today's rapidly evolving healthcare landscape, cybersecurity is a critical component of patient safety and regulatory approval. At CMS SciDoc, in collaboration with our industry-leading partners, we provide comprehensive cybersecurity testing and compliance services to help medical device manufacturers meet stringent regulatory requirements while safeguarding patient data and device integrity. Our Cybersecurity Testing Services Include: ✔ Vulnerability Assessments & Penetration Testing ✔ Threat Modeling & Risk Assessments ✔ Wireless & Network Security Evaluations ✔ Software Security & Code Analysis ✔ Regulatory Documentation & Compliance Support Why Choose us? 🔹 Regulatory Expertise – Comprehensive support in meeting FDA, MDR, TGA, and global cybersecurity requirements 🔹 Proactive Risk Mitigation – Identifying vulnerabilities before they become threats 🔹 Comprehensive Security Testing – Covering hardware, software, and network security 🔹 Accelerated Market Approval – Minimizing compliance risks and avoiding costly regulatory delays 🔹 Commitment to Patient Safety – Strengthening security measures to protect lives Ensure your medical device is secure, compliant, and market-ready with our expert cybersecurity testing services. Contact CMS SciDoc today to schedule a consultation. #medicaldevices #tga #fda #mdr #SaMD #cybersecuritytesting

𝗖𝘆𝗯𝗲𝗿𝘀𝗲𝗰𝘂𝗿𝗶𝘁𝘆 𝗥𝗲𝘃𝗼𝗹𝘂𝘁𝗶𝗼𝗻: 𝗪𝗵𝗮𝘁 𝗬𝗼𝘂 𝗡𝗲𝗲𝗱 𝘁𝗼 𝗞𝗻𝗼𝘄 𝗔𝗯𝗼𝘂𝘁 𝘁𝗵𝗲 𝗟𝗮𝘁𝗲𝘀𝘁 𝗨.𝗦. 𝗙𝗗𝗔 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗳𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 The U.S. Food and Drug Administration (FDA) has significantly tightened its requirements for medical device manufacturers. In its most recent guidance, Cybersecurity has been elevated to the status of a critical component of patient safety and product quality. Here are the two essential pillars driving the FDA's new approach: 𝟭. 𝗦𝗲𝗰𝘂𝗿𝗶𝘁𝘆 𝗯𝘆 𝗗𝗲𝘀𝗶𝗴𝗻 (𝗦𝗯𝗗) The FDA mandates that security must be an integral part of the medical device from the earliest design phase, not merely an add-on. This necessitates: • Risk Management: Manufacturers must document how they have identified, analyzed, and mitigated cybersecurity risks throughout the product’s entire Total Product Life Cycle (TPLC). • Technical Requirements: Compliance requires implementing technical controls such as encryption, strong access controls, authentication mechanisms, and the capacity to detect and respond to security incidents. 𝟮. 𝗖𝗼𝗺𝗽𝗿𝗲𝗵𝗲𝗻𝘀𝗶𝘃𝗲 𝗣𝗿𝗲𝗺𝗮𝗿𝗸𝗲𝘁 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 For a medical device to be granted market approval, the manufacturer must provide the FDA with extensive cybersecurity documentation. The key required elements include: • SBOM (Software Bill of Materials): A mandatory list of all commercial, proprietary, and open-source software components used in the device. This ensures transparency and enables rapid vulnerability identification. • Cybersecurity Management Plan: A formal plan outlining how the manufacturer will continuously monitor for vulnerabilities and deliver security updates (patches) throughout the device's lifecycle post-market. 𝗦𝘂𝗺𝗺𝗮𝗿𝘆 The new FDA guidance unequivocally treats cybersecurity not as an optional feature, but as a fundamental prerequisite for deeming a medical device safe and effective. Manufacturers must demonstrate proactivity and a long-term commitment to maintaining device security after the product has been placed on the market. #cybersecurity #medicaldevice #FDA

ISO/IEC 27001 Certification – A Reflection on Product Security and Digital Trust Recently, B. Braun received the ISO/IEC 27001 certification – a noteworthy step that highlights our ongoing commitment to secure, resilient, and trustworthy product environments. This achievement is not just about compliance; it’s about reinforcing the maturity of our pre- and post-market processes, and ensuring that every product is developed, manufactured, and shipped within a secure and internationally recognized framework. Security doesn’t stop at the product itself. It extends to the entire ecosystem – the environment in which innovation happens. ISO/IEC 27001 provides a strong foundation for building cyber agile products, enabling us to establish resiliency and foster digital trust. This progress is part of a broader MedTech industry movement. Through collaboration with associations like APACMed and MedTech Europe, and in close dialogue with regulators and policymakers, we work to implement and continuously improve harmonized frameworks. The focus remains on leveraging proven standards – those that have demonstrated their efficiency over decades. At B. Braun, product security, including cybersecurity, remains a top priority. Achievements like this are not just milestones; they are evidence of the industry’s evolution and its ability to deliver strong, reliable results. They reflect our commitment to building a mature, secure environment that inspires confidence and trust. #CyberSecurity #ISO27001 #ProductSecurity #DigitalTrust #MedTech #BBraun #HealthcareInnovation #CyberResilience #SecurityByDesign #APACMed #MedTechEurope https://lnkd.in/eBCKNQT8

October is Cybersecurity Awareness Month – and at MedAcuity, we’re spotlighting the critical importance of cybersecurity in medical device development. Regardless of whether a medical device is “connected” or not, cybersecurity is not optional — it's essential. A single vulnerability can impact not just data privacy, but patient safety and clinical outcomes. At MedAcuity, we partner with medical device companies to integrate cybersecurity best practices across the software development lifecycle — from architecture and threat modeling to secure coding and regulatory compliance. Cybersecurity has become so critical that the FDA has elevated it to Security Risk Management, on-par with Safety Risk Management. Whether you're designing with the FDA’s premarket guidance in mind or working to meet standards like ISO/IEC 81001-5-1 and UL 2900, our experts help you navigate the complex intersection of safety, security, and innovation. 📢 This Cybersecurity Awareness Month, we encourage industry leaders to ask: ·      Is security baked into your design — or bolted on later? ·      Are you prepared for the threat landscape of connected care? ·      Is your development team equipped with the right tools and expertise? 👉 Contact us to learn how MedAcuity can help strengthen your device cybersecurity from day one: https://lnkd.in/ey6FHnGv #CyberSecurityAwarenessMonth #MedTechCybersecurity #MedicalDevices #MedAcuity #SoftwareDevelopment #ConnectedCare #PatientSafety #CyberResilience

Learn how the FDA prioritizes cybersecurity in medical device submissions, and what steps sponsors should take to ensure compliance, patient safety, and faster approvals.

🔐 EU Cybersecurity Act: Raising the Bar for Medical Device Security in Europe. As connected medical devices become increasingly software-defined, the EU Cybersecurity Act marks a decisive step toward building a trusted digital ecosystem across Europe. This regulation doesn’t just strengthen the EU Agency for Cybersecurity (ENISA) — it introduces a pan-European certification framework that defines how ICT products, software, and services will be assessed and recognized for cybersecurity assurance. For the medical technology sector, this shift is profound: ⚙️ Cybersecurity certification will soon become a prerequisite for market access. 🏥 Devices impacting patient safety will require “Substantial” or “High” assurance levels, proving security-by-design and continuous vulnerability management. 💶 Non-compliance can lead to fines up to €15M or 2.5% of global turnover — on par with GDPR. At BlackBerry QNX, we view this as more than a compliance challenge — it’s a strategic opportunity. Our mission is to help medical innovators embed trust at the core of their systems, through a platform that already integrates: ✅ Security-by-design architecture (microkernel isolation, secure boot, privilege separation) ✅ Proven certification heritage (IEC 62304, ISO 26262, IEC 61508) ✅ Processes ready for EU Cybersecurity Act and Cyber Resilience Act alignment Organizations that start aligning now will not only simplify future compliance, but also gain a competitive edge by demonstrating verifiable cybersecurity and patient safety. 🩺 Building secure, connected, and compliant medical systems isn’t optional anymore — it’s the foundation of digital trust. #Cybersecurity #MedTech #EURegulations #CyberResilience #QNX #EmbeddedSystems #PatientSafety #DigitalTrust #MedicalDevices #CyberSecurityAct https://lnkd.in/dGJXbYqU

⌛1 Day left to register! CSA Group Beyond Compliance: Engineering Cybersecurity into Connected Medical Devices 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. 📰 Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter

New from NEMECYS: SSDP – Secure Software Development Pipelines for Medical Applications Developed by Information Catalyst, SSDP integrates DevSecOps principles into the full lifecycle of medical software development—embedding security from design to deployment. 🔐 Built for SaMD providers, healthcare developers, and medical device manufacturers, SSDP automates testing (SAST/DAST), manages supply chain risks, and supports compliance with benchmarks like CIS and medical device regulations. It’s an open-source framework designed to help teams build secure, compliant, and resilient medical applications—faster. Download the brochure to learn more: https://lnkd.in/duH3h8GJ #NEMECYS_eu #Cybersecurity #SaMD #DevSecOps #MedicalDevices #DigitalHealth #HorizonEurope #SSDP

Your GMP facility may be secure but is your data? With FDA and EMA shifting focus toward cybersecurity in pharma manufacturing, data integrity now goes beyond ALCOA+. Hackers don’t need to break into your cleanroom; they can cripple your MES, LIMS, or SCADA systems from a laptop. ⸻ ⚠️ Where Pharma Is Most Vulnerable ❌ Outdated PLCs and SCADA with no patching strategy. ❌ Shared logins for critical GMP systems. ❌ No validation of cybersecurity controls in CSV/CSA. ❌ Backup servers not tested under real attack scenarios. ⸻ ✅ Cybersecurity in GMP Playbook 1️⃣ Patch Management — Treat IT patches like calibration: scheduled, documented, verified. 2️⃣ Access Controls — Unique logins, 2FA, and periodic access reviews. 3️⃣ CSV Meets Cyber — Validate not just workflows, but security features (audit trail lock, encryption). 4️⃣ Backups & Recovery — Test your restore process quarterly. 5️⃣ Vendor Oversight — Audit suppliers for cybersecurity compliance, not just GMP. ⸻ 💡 Takeaway: Cybersecurity is GMP. A data breach or ransomware attack is just as damaging as a contamination event—and regulators are starting to treat it that way. #ThePharmaUniversity #PharmaUni #Cybersecurity #DataIntegrity #CSA #GMPCompliance #PharmaEngineering #ValidationLife #FDA #USA