Ebani D.’s Post

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

Regulatory delays are a major hurdle for MDMs. Discover why demonstrating secure product development, security-specific documentation like SBOMs, and successful risk mitigation are critical for FDA approval. Our latest blog delves into key areas crucial for strengthening #cybersecurity in #medicaldevices, from regulatory requirements to emerging trends. Prioritizing cybersecurity and adhering to regulatory requirements not only protects patients but also ensures a smoother approval process. Read the blog to find out what you're missing when it comes to reaching market approval: https://lnkd.in/gT2Q_fag

Every 40 seconds, a medical system falls prey to cyber-attacks. With $7 billion lost to healthcare cyber-attacks last year, the urgency for compliance has never been more evident. Non-compliance isn’t just a risk; it could result in losing your devices in the market! Read this latest white paper, which provides insights into essential testing methodologies and actionable steps to navigate the new FDA mandates for SaMD. Discover how proactive compliance not only safeguards your devices but also protects your financial investments - https://lnkd.in/gRD8YgUT #FDACompliance #MedicalDevices #Cybersecurity

Mark your calendars now for January 16th at 11 am ET to learn how to achieve cybersecurity & compliance readiness for your medical devices! https://bit.ly/3OYMlrK Joined by our friends at Deep Armor, we will discuss the essential cybersecurity and regulatory activities that medical device manufacturers need to be aware of. We'll talk about vulnerabilities, their impact, and what businesses can do to stop bad actors from taking advantage of them. Finally, we provide case studies and an overview of how Deep Armor can assist the MedTech community in completing regulatory audits and raising the bar for cybersecurity for their products. Don't miss out on this informative session!

Hackers target medical devices; one breach could jeopardize patient safety, compliance, and reputation. As a medical device manufacturer, you’re not just delivering products – you’re delivering safety, trust, and innovation. However, with cyber threats on the rise, trust is only as strong as your security measures. This is where Good Manufacturing Practices (GMP) come into play—they’re not just about quality control; they’re about future-proofing your devices against evolving threats. 🔍 In one of our latest blogs, we explore how GMP can help you: ✅ Mitigate cybersecurity risks to protect sensitive data and patient safety ✅ Achieve FDA compliance with streamlined, secure processes ✅ Maintain your reputation as a leader in a competitive and highly regulated industry Cybersecurity isn’t just a technical issue—it’s a manufacturing responsibility. Don’t wait for a breach to act. Discover how implementing GMP can secure your devices and safeguard your company’s future. 👉 Read the full blog now: (https://lnkd.in/gUyrHVDM) #MedicalDeviceManufacturers #CybersecurityCompliance #GMPForSafety #BlueGoatCyber #InnovationWithSecurity

The healthcare sector, with its vast stores of sensitive patient information and reliance on technology for critical operations, has become a prime target for cyberattacks. Ensuring robust cybersecurity is not just a matter of protecting data but also of safeguarding patient health and safety. This blog explores the unique cybersecurity challenges faced by the healthcare industry and the pivotal role of the FDA in addressing these challenges. Read more here: https://lnkd.in/eYEA9vRW

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

In recent years, the landscape of medical device cybersecurity has shifted dramatically from a concept to a crucial industry imperative. The FDA's stringent requirements emphasize that cybersecurity must be a fundamental consideration in product development and compliance measures. As we navigate this evolving arena, staying informed is essential. Discover more about these changes and their impact on the industry here: https://okt.to/VkFxz9

Missed the live session on October 9th? No problem! You can now watch the replay of our exclusive webinar, "Managing Compliance with the FDA's SBOM Requirements," hosted by FOSSA and Cortex Frazier Jr., featuring Trevor Slattery, Director of Medical Device Cybersecurity at Blue Goat Cyber. This webinar is an essential resource for anyone involved in the medical device industry, healthcare cybersecurity, or regulatory affairs. Trevor breaks down the FDA’s Software Bill of Materials (SBOM) requirements, offering actionable strategies for navigating this complex compliance landscape. You’ll learn about: - FDA Compliance: Understanding the new SBOM regulations and their impact on medical devices. - Cybersecurity Best Practices: Mitigating vulnerabilities and securing your device supply chain. - Protecting Patient Data: Ensuring data integrity and safety while meeting FDA expectations. If your organization develops medical devices or deals with healthcare cybersecurity, this webinar offers practical insights that can help you stay ahead of regulatory demands while protecting your systems and your patients. 🔐 Watch the Replay Here: https://lnkd.in/e5d365cm Stay informed and compliant with the latest FDA requirements to safeguard the future of healthcare. 💻 #Cybersecurity #HealthcareInnovation #MedicalDevices #SBOMCompliance #FDACompliance #BlueGoatCyber

What's changed in a year with FDA in #medicaldevice #cybersecurity? Find out what Medcrypt has seen through our many services engagements and interactions with #MDMs and the #FDA: