MedISAO的动态

Missed the webinar on December 18th? The recording is now available! In "Leveraging ISAOs for FDA Cybersecurity Strategy in the Medical Device Industry," speakers dive into how Information Sharing and Analysis Organizations (ISAOs) can be a game-changer in navigating FDA cybersecurity expectations. From SBOMs to vulnerability management, explore how ISAOs empower medical device manufacturers to stay ahead of evolving regulatory requirements and cybersecurity threats. Watch now: https://lnkd.in/geguNM35 #ISAOs #MedicalDeviceCybersecurity #MedTech #MedicalDevices #HealthTech

Meeting the FDA's rigorous cybersecurity requirements for premarket submissions presents significant challenges for medical device manufacturers. From building a comprehensive threat model to aligning with detailed regulatory expectations, even minor gaps in preparation can result in delays or rejections—disrupting product launch timelines and increasing costs. Blue Goat Cyber brings extensive expertise in addressing these challenges, guiding manufacturers through the complexities of cybersecurity compliance. With a structured, risk-based approach, we help ensure your submissions are thorough, compliant, and positioned for approval. Achieve clarity and confidence in your premarket journey. Reach out today: https://bluegoatcyber.com #MedicalDeviceCybersecurity #FDACompliance #CyberRiskManagement #PremarketSubmissions #MedicalDeviceInnovation

Navigating the FDA’s stringent cybersecurity requirements can be daunting for medical device manufacturers. Minor gaps in preparation can lead to delays or rejections, disrupting timelines and increasing costs. At Blue Goat Cyber, we’ve made it our mission to simplify this process. By applying a risk-based, systematic approach, we guide manufacturers to develop thorough, compliant premarket submissions that meet FDA expectations. Let’s tackle these challenges together and ensure your innovation reaches patients faster. ?? Let’s connect: https://bluegoatcyber.com

Are you attending H-ISAC Fall summit? If so, make sure you catch Naomi Schwartz, Medcrypt's VP of Regulatory Services, on Dec 5th presenting: "Insights on Cybersecurity-Related Regulatory Deficiencies in Medical Devices." Key takeaways: - Impact of security breaches on patient safety, clinical ops, and data integrity. - Common cybersecurity deficiencies in devices & actionable strategies to address them. - What HDOs should ask MDMs when procuring systems. Connect with Bob Lyle or Seth Carmody at [email protected] ahead of the summit to schedule a time to meet up or to discuss your cybersecurity needs. #HISAC2024 #Cybersecurity #MedicalDevices #MedcryptInsights #PatientSafety #MedicalDeviceManufacturers

The realm of medical device cybersecurity has transformed significantly from a mere idea to a vital necessity for the industry. The FDA has implemented strict guidelines, underscoring that cybersecurity needs to be integral to both product development and compliance processes. As we adapt to these changes, it is crucial to remain updated. Learn more about these developments and their implications for the industry here: https://okt.to/ASjxuG

We are excited to share our latest blog post that highlights a critical security concern: the Contec CMS8000 patient monitor contains a backdoor vulnerability. This discovery raises significant implications for patient safety and data integrity in healthcare settings. In our analysis, we discuss the potential risks associated with this backdoor and emphasize the importance of robust cybersecurity measures in medical devices. For those in the healthcare and cybersecurity sectors, it's essential to stay informed about these developments. We encourage you to read the full article for detailed insights and recommendations on addressing such vulnerabilities. Explore the blog post here: https://ift.tt/7206fiu.

The FDA’s focus on authentication and authorization is more important than ever. One of our latest blogs dives into the essential security controls every medical device manufacturer must implement to meet FDA cybersecurity requirements and protect patient safety. ? What you’ll learn: - Why robust authentication and authorization are critical. - Key FDA expectations for medical device cybersecurity. - Practical steps to strengthen your device security. ?? Don’t leave compliance and patient safety to chance. Dive into the details and ensure your devices meet regulatory standards while protecting sensitive data. ?? Read the full blog here: (https://lnkd.in/gV_C7T2S) #MedicalDeviceCybersecurity #FDACompliance #CybersecurityBestPractices #BlueGoatCyber #PatientSafety #HealthcareSecurity

Medical device cybersecurity has become a vital industry focus. The FDA's strict standards highlight the need for cybersecurity in product development and compliance. It's important to stay updated on these changes and their effects on the industry. Learn more here: https://okt.to/KumbGr

??Does connecting the omnibus and the FDA’s medical device cybersecurity guidelines keep you up at night? Me too. ?? Join me for a webinar to walk you through the compliance journey and avoid being hit with the big bad refuse to accept (RTA). https://lnkd.in/dbbH5Yhy #ProductSecurity #CyberSecurity #FDA #medicaldevices #compliance

Regulatory & compliance audits often take a LOT of time and involve back & forth among the people involved. If you are working in a regulated vertical, say healthcare or medical devices, our time-tested advice is: Start Early. For other learnings on how to achieve a high security bar AND regulatory approvals for medical devices, join us next week. Link to our free webinar, in partnership with MassMEDIC is below. #regulatory #compliances #healthcare #medtech #medtechsecurity #healthcaresecurity