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Medcrypt
США
Добавлен 8 июн 2020
Medcrypt brings security features to medical devices, from pacemakers to surgical robots, in a few lines of code. The exponential growth of connected devices in healthcare combined with the FDA mandate to “bake in” security into devices means the best solution is one that secures devices, not the hospital network.
Medcrypt | DEKRA Webinar: Navigating Regulatory Complexity: Achieving Market Approval
Originally recorded September 25, 2024
In the global medical device market, navigating the complex and varied regulatory frameworks is a critical challenge for manufacturers aiming to ensure trusted communication within their devices. With regulatory environments such as the FDA in the U.S., the Common Criteria (CC), HIPAA, FIPS, and the European Union’s stringent standards-driven regulations, achieving market approval requires a nuanced approach that respects both mandatory requirements and optional standards.
Join Medcrypt and DEKRA, the world’s largest independent expert organization in testing, inspection, and certification, for an insightful webinar focused on guiding medical device ex...
In the global medical device market, navigating the complex and varied regulatory frameworks is a critical challenge for manufacturers aiming to ensure trusted communication within their devices. With regulatory environments such as the FDA in the U.S., the Common Criteria (CC), HIPAA, FIPS, and the European Union’s stringent standards-driven regulations, achieving market approval requires a nuanced approach that respects both mandatory requirements and optional standards.
Join Medcrypt and DEKRA, the world’s largest independent expert organization in testing, inspection, and certification, for an insightful webinar focused on guiding medical device ex...
Просмотров: 33
Видео
Webinar: HSCC Cybersecurity Working Group: 5 Year Cybersecurity Strategic Plan
Просмотров 88Месяц назад
Originally recorded on August 20, 2024 Under U.S. critical infrastructure policy coordinated by the U.S. Department of Homeland Security Cybersecurity and Infrastructure Security Agency (CISA), Healthcare is designated among 15 other industry sectors as “critical infrastructure” and is represented by an industry-organized “sector coordinating council (SCC).” The Health Sector Coordinating Counc...
Webinar: Medical Device Software Cybersecurity Leveraging SBOMs and Cross Industry Practices
Просмотров 2052 месяца назад
Originally recorded on 7/17/24 This webinar brought to you by MedISAO will empower medical device manufacturers with proactive strategies to manage software component vulnerabilities. By examining solutions from IT and the industrial control space, we'll uncover how other industries have successfully navigated these challenges and discuss why the medical device industry differs from the rest of...
Vulnerability Brief for RegreSSHion (CVE-2024-6387)
Просмотров 1462 месяца назад
In this video, Medcrypt VP Product Om Mahida discusses the vulnerability released on July 1st, 2024. Resources in the video: www.qualys.com/2024/07/01/cve-2024-6387/regresshion.txt nvd.nist.gov/vuln/detail/CVE-2024-6387 securityboulevard.com/2024/07/regresshion-cve-2024-6387-a-targeted-exploit-in-the-wild/ github.com/acrono/cve-2024-6387-poc unit42.paloaltonetworks.com/threat-brief-cve-2024-638...
How to Use Cybersecurity as a Competitive Advantage for M&A
Просмотров 164 месяца назад
In this interview with Surgical Robotics Technology, Vidya Murthy, COO at MedCrypt discusses the importance of cybersecurity and how to use it as a competitive advantage for M&A in 2024. The interview covers:- 0:13 - Why is security for MDMs important in M&A? 1:10 - How can organizers use cybersecurity certifications as a differentiator and how can it influence the valuation of a company? 2:58 ...
FDA Reality Check: Do You Stack up to the New Guidelines?
Просмотров 404 месяца назад
In this interview from Surgical Robotics Technology, Vidya Murthy, COO at MedCrypt discusses the biggest challenges companies face when creating a cybersecurity strategy, how a company can tell if they are on the right track and the common deficiencies found within medical devices. The interview covers:- 0:13 - What are the regulators expectations? 0:52 - What are some of the biggest cybersecur...
Navigating Med Device Cybersecurity Waters: Regulatory Similarities & Differences Between EU & US
Просмотров 4925 месяцев назад
Webinar originally recorded on May 2, 2024 Although global medical device regulators have increasingly provided regulations and guidance on cybersecurity there are notable differences in the way regulators include cybersecurity, and related safety concerns, in their overall regulatory framework. Yet, similarities exist that allow medical device manufacturers to optimize their cybersecurity effo...
Medcrypt FDA Readiness Service
Просмотров 175 месяцев назад
Optimize your path to FDA cybersecurity readiness. We partner with you to ensure your devices can achieve the highest level of regulatory review, as well as develop cybersecurity programs that scale with you. Get your secure medical devices to market on or even ahead of schedule, with peace of mind. Medical device cybersecurity is a hard problem to solve. Our Services team provides actionable r...
Webinar: I have an SBOM. Now what?
Просмотров 3445 месяцев назад
Webinar originally recorded on April 3, 2024. Are you under the impression that having a Software Bill of Materials (SBOM) is the end of your compliance journey? Think again. The FDA views SBOM as just one piece of a comprehensive pre- and post-market vulnerability management program. It's about more than just listing components-it's about understanding and managing vulnerabilities throughout t...
Medcrypt Helm: SBOM and Vulnerability Management
Просмотров 636 месяцев назад
Need to prioritize critical vulnerabilities? Looking for simplified SBOM compliance? Helm provides continuous integration, analysis, and transparency of the evolving state of your medical device software supply chain to proactively identify and mitigate your most exploitable vulnerabilities. Get the latest information on any changes to your vulnerabilities, including new exploits and threats, a...
Webinar: How healthcare organizations navigate government regulatory activity impacting open source
Просмотров 626 месяцев назад
Webinar originally recorded on March 6, 2024. In 2024, cybersecurity risk impacts patient outcomes, doctor burnout, and care success at nearly every healthcare organization. Many organizations are making investments on their own to ensure they are protected, but they are also paying close attention to cybersecurity guidance and regulations published by the federal government. Several government...
Webinar: Vulnerability Lifecycle Management Check Yourself Before You Wreck Yourself 2/14/24
Просмотров 2097 месяцев назад
Originally recorded 2/14/24 As outlined in the FDA premarket cybersecurity guidance, medical device manufacturers should produce a Secure Product Development Framework, or SPDF. An SPDF outlines processes for reducing the number and severity of vulnerabilities, through discovery to monitoring. Manufacturers face a variety of pain points when existing processes aren’t meeting FDA standards, whic...
Medcrypt Webinar: Tackling Stock Deficiency Letters to Achieve FDA Approval
Просмотров 1439 месяцев назад
Originally recorded on Dec 21, 2023. A large proportion of Medical Device Manufacturers (MDMs) receive deficiency letters from the Food and Drug Administration (FDA) requesting additional information in their 510k(s), de novo and PMA submissions. Navigating these deficiency letters can be a confusing and downright tumultuous task for MDMs. There are a number of things to consider when submittin...
Cybersecurity and AI/ML are Inextricably Linked when Dealing with the FDA
Просмотров 1219 месяцев назад
Medcrypt's VP of Services Naomi Schwartz spoke at the AI True Quality Summit Series, a virtual event that offers a comprehensive deep dive into the fusion of AI and MedTech. In this webinar, Naomi discusses the history of AI/ML regulation at the FDA, as well as methods of approaching cybersecurity for AI/ML devices when submitting to the FDA. To learn more about Medcrypt, visit our website: www...
FDA Strategy: Improving the Safety of Medical Devices - Naomi Schwartz, VP of Services, Medcrypt
Просмотров 419 месяцев назад
In this interview, Naomi Schwartz, Vice President of Services at Medcrypt, discusses her overall concerns with cybersecurity, the RTA policy, and improving the safety of medical devices. The interview covers: 0:13 - What are the overall concerns with cybersecurity and medical devices? 0:56 - Please tell us about the RTA policy. 1:34 - How serious is the FDA about the RTA strategy and what makes...
Unpacking FDA Guidance: Quality System Considerations and Content of Premarket Submissions
Просмотров 77411 месяцев назад
Unpacking FDA Guidance: Quality System Considerations and Content of Premarket Submissions
Webinar: The FDA ‘Cybersecurity Refuse to Accept Policy’ will affect Medical Device Manufacturers!
Просмотров 528Год назад
Webinar: The FDA ‘Cybersecurity Refuse to Accept Policy’ will affect Medical Device Manufacturers!
Encryption, Key Management & PKI Key Lifecycle Management Webinar
Просмотров 229Год назад
Encryption, Key Management & PKI Key Lifecycle Management Webinar
Medical Device Cybersecurity with MedCrypt: Encryption, Key Management & PKI
Просмотров 388Год назад
Medical Device Cybersecurity with MedCrypt: Encryption, Key Management & PKI
Webinar: FDA Refuse to Accept RTA Guidance for Premarket Submissions
Просмотров 142Год назад
Webinar: FDA Refuse to Accept RTA Guidance for Premarket Submissions
Webinar: Assessing Medical Device Portfolio Cybersecurity Risk in Revenue Dollars
Просмотров 114Год назад
Webinar: Assessing Medical Device Portfolio Cybersecurity Risk in Revenue Dollars
Webinar: Medical Device Cybersecurity Regulatory Update
Просмотров 1 тыс.Год назад
Webinar: Medical Device Cybersecurity Regulatory Update
The Impact of Medical Device Cybersecurity on Medical Device Manufacturers
Просмотров 43Год назад
The Impact of Medical Device Cybersecurity on Medical Device Manufacturers
How Medical Device Cybersecurity Impacts Patients
Просмотров 20Год назад
How Medical Device Cybersecurity Impacts Patients
The Impact of Medical Device Cybersecurity on Regulators
Просмотров 32Год назад
The Impact of Medical Device Cybersecurity on Regulators
The Impact of Medical Device Cybersecurity on Healthcare Providers
Просмотров 58Год назад
The Impact of Medical Device Cybersecurity on Healthcare Providers
Medical Device Cybersecurity Terminology and Fundamental Concepts
Просмотров 2482 года назад
Medical Device Cybersecurity Terminology and Fundamental Concepts
Galen Data Webinar: The Business Case for Cybersecurity in Medical Devices
Просмотров 822 года назад
Galen Data Webinar: The Business Case for Cybersecurity in Medical Devices
Demystifying FDA Cybersecurity Premarket Guidance
Просмотров 5332 года назад
Demystifying FDA Cybersecurity Premarket Guidance
Should be checking vulnerabilities at least monthly, if not more frequently as well as have a plan to drop what you are doing and fix the problem if required.
This is Awesome, UC Berkley has made a electrochemical biosensor, made by Iota, Astella, and Biospace, this device is hi-jacked daily , used for torture physically and mentally, a sensor put by the ear canal vibrates so to hear the voice on the other side from a smart phone,. also hears your surroundings and can manipulate your thoughts,. a very dangerous medical device and is used for torturing for humans.
what would you suggest if you have a medical device embeded in your body and it is being continualy manipulated , my device is an Iota biosensors, now made also with attella, and biospace. how should i get help with this , i have been hacked for eight years now.
💥 𝖕𝖗𝖔𝖒𝖔𝖘𝖒
Do you have internships/Co-Op opportunities available for students?