Blue Goat Cyber’s Post

The journey to getting your medical device approved by the FDA can be daunting, especially when it comes to #cybersecurity. With increasing regulatory requirements, ensuring your device meets the highest standards is more important than ever. Information Sharing and Analysis Organizations (ISAOs) provide a collaborative platform for sharing critical threat intelligence and best practices, helping medical device manufacturers stay ahead of regulatory expectations. Discover how joining an ISAO can make a difference in your regulatory strategy and enhance the cybersecurity of your #medicaldevices: https://lnkd.in/gtN9jvHK

🛡️ Follow FDA Guidelines for Devices! 🛡️ Are your medical devices compliant with FDA cybersecurity guidelines? 📋 Ensuring that all devices meet these standards during development and deployment is crucial for patient safety. Imagine the risks of non-compliance! Here’s why it matters: - Protect sensitive patient data. 🔒 - Avoid costly delays in device approval. ⏳ - Enhance the overall safety and effectiveness of your products. ✅ Let’s prioritize cybersecurity in healthcare! How do you ensure your devices meet FDA guidelines? 💬👇 #Cybersecurity #MedicalDevices #FDAGuidelines #PatientSafety #HealthcareInnovation

Our next webinar with FDA and live Q&A will be this Wednesday, April 3rd! Register NOW to learn more about the Premarket Guidance #FDA #SBOM #Cybersecurity #Medicaldevices #Premarketguidance

Are you a member of Medical Device Manufacturers Association (MDMA)? If yes, please join Medcrypt as we share tips on how to work with #fda to achieve their expectations for the #cybersecurity of your #medicaldevice, in this members-only webinar!

Did you miss our August webinar? No worries! You can still catch the replay! Our expert panel explored the critical topic of FDA cybersecurity requirements for medical devices, sharing invaluable strategies for a smooth submission and clearance process. Watch here: https://hubs.la/Q02SX1cl0 #FDACompliance #Cybersecurity #MedTech #SBOM #MedicalDevices #HealthcareSecurity #VigilantOps #WebinarReplay #FDASubmission #eSTAR #RegulatoryAffairs

𝙏𝙝𝙚 𝙁𝘿𝘼 𝙖𝙙𝙫𝙤𝙘𝙖𝙩𝙚𝙨 𝙛𝙤𝙧 𝙛𝙪𝙯𝙯 𝙩𝙚𝙨𝙩𝙞𝙣𝙜 𝙬𝙝𝙚𝙣 𝙩𝙚𝙨𝙩𝙞𝙣𝙜 𝙢𝙚𝙙𝙞𝙘𝙖𝙡 𝙙𝙚𝙫𝙞𝙘𝙚𝙨. This is stated in the FDA's guidance on cybersecurity in medical devices and in AAMI TIR 57:2016, which is recognized by the FDA as state-of-the-art. 𝗜𝗳 𝘆𝗼𝘂 𝗱𝗼𝗻’𝘁 𝗳𝗼𝗹𝗹𝗼𝘄 𝘁𝗵𝗲𝘀𝗲 𝗴𝘂𝗶𝗱𝗲𝗹𝗶𝗻𝗲𝘀, 𝘆𝗼𝘂 𝘄𝗼𝗻’𝘁 𝗴𝗲𝘁 𝗺𝗮𝗿𝗸𝗲𝘁 𝗮𝗽𝗽𝗿𝗼𝘃𝗮𝗹 𝗳𝗼𝗿 𝘁𝗵𝗲 𝗨𝗦 𝗺𝗮𝗿𝗸𝗲𝘁 🇺🇲 If you're involved in medical device development, download our white paper to learn more about: ➡ The FDA's cybersecurity requirements ➡ 4 reasons why fuzzing is highly recommended ➡ The role of fuzzing in compliance Many thanks to Lorit Consultancy and Verena Wieser for guiding us through the intricacies of medical security regulations and sharing their expertise with us. Claim your free white paper here: https://lnkd.in/d-RtMMuK #fuzztesting #medicaldevices #cybersecurity

Navigating the complex landscape of cybersecurity regulations for medical devices just got easier. Medcrypt partnered with the Johner Institut GmbH to create a comprehensive guide on staying ahead of evolving regulations while ensuring patient safety and product security. Key global regulatory expectations from the FDA and EU are highlighted, along with insights into common challenges that result in approval and rejections. Download the full white paper here and ensure your team is equipped to meet international regulatory challenges head-on: https://lnkd.in/gqvJVjK6 #cybersecurity #meddevice #healthcaresecurity #securityresearch #whitepaper

Deep Armor, in collaboration with MassMEDIC , invites you to a webinar on “Achieving Cybersecurity & Compliance Readiness for Healthcare & Medical Devices.” Join us to explore key strategies for strengthening the cybersecurity posture of your healthcare devices and SMDs while ensuring compliance with healthcare standards. Learn about the essential steps for FDA compliance and how Deep Armor can support you in the process. Date: January 16, 2025 Register here: https://lnkd.in/gnfBE9jd #Cybersecurity #HealthcareSecurity #MedicalDevices #Webinar #FDACompliance #DeepArmor #MASSMEDIC

The second annual Medical Device Cybersecurity Maturity Benchmark Report by Medical Device Innovation Consortium (MDIC) is out. This comprehensive report provides critical insights into the current state of cybersecurity within the medical device industry, highlighting both progress and areas needing improvement. As the healthcare landscape becomes increasingly digital, it is crucial to stay informed and proactive in addressing cybersecurity risks. This report is an invaluable resource for medical device manufacturers, healthcare providers, and all stakeholders committed to patient safety and data security. 👉 Don't Miss Out! Register for an insightful webinar where industry experts will discuss the report's findings and the importance of cybersecurity posture. 📅 Webinar Details: Date: Wednesday, June 5th Time: 12PM EST Registration Link: https://lnkd.in/eDbQxi2R #Cybersecurity #MedicalDevices #MDIC #Webinar #PatientSafety #MedicalDeviceManufacturers Read full Article: https://lnkd.in/eMCrt8gA

🌐In today's healthcare industry, medical device manufacturers face a critical challenge: balancing the need for stringent cybersecurity to ensure patient safety while safeguarding sensitive patient data and maintaining privacy standards. With the FDA's evolving regulations, manufacturers must prioritize data integrity and device security to protect against cyber threats while complying with complex regulatory frameworks. This blog (link below) explores how industry leaders tackle this privacy vs. safety dilemma, implementing best practices to ensure robust cyber defenses without compromising privacy. Discover the strategies that can help you stay ahead of the curve in medical device manufacturing, ensure compliance, and protect patients. Read the full article 👉 https://lnkd.in/gPtifBBT #MedicalDevices #Cybersecurity #PatientSafety #DataPrivacy #FDACompliance #HealthcareSecurity #DataIntegrity #BlueGoatCyber #DeviceManufacturing