Brian Bell’s Post

Interested in a new kind of cybersecurity training that will help your team be more efficient and successful on that next project? Cybersecurity requirements are maturing rapidly for medical devices and this is leading to some very specific documents that will need to be produced to have a successful regulatory submission. I've created this new course for the upcoming Archimedes Halthcare Week in NOLA. This course is designed to guide updates to yoru QMS that will help you create the right documents during your development so you are more submission ready at the end of development. This will align with the recent updates to eSTAR that specify many new documents that will be needed to pass the Refuse to Accept Checklist and enter the submission process for FDA. Sign up today and join us for this important topic! Archimedes Center for Health Care and Medical Device Cybersecurity at Northeastern University MedSec

Excellent paper that pulls the multi-faceuted technical & regulatory issues together in this ever evolving topic of Cybersecurity. Well worth the read!

“Medigate’s ability to automatically identify and classify medical devices on our network has been a valuable feature. This has allowed us to have a clear inventory of devices, which is crucial for security.” 🔎 Find out why The Ohio State University Wexner Medical Center, one of America’s top-ranked academic health centers, opted to implement Medigate by Claroty to build a robust cybersecurity strategy in this new case study: https://bit.ly/41QcrTG

Healthcare institutions in the United States experienced a significant increase in cyberattacks. 🏥 To mitigate the risks, we must prioritize preventative measures and detection. Robust security protocols protect the organizations' and patients' sensitive data and ensure the seamless functioning of healthcare organizations. 🔒 Our team of Life Sciences specialists is dedicated to providing secure development services for every project in Clinical Trials. 🧬 Additionally, our colleagues from AROBS Engineering create secure and certified solutions for medical devices, while the Berg Software team guarantees safe data handling in developing Biomedical solutions. Gain a deeper understanding of the role of cybersecurity in the healthcare technology landscape. Get inspired to safeguard your organization, download our whitepaper today, and connect with our specialists! 📑🔒 https://lnkd.in/dC26Rayc   #AROBS #LifeSciences #ClinicalTrials #MedicalDevices #LabAutomation #HealthcareInnovation #Cybersecurity #MedicalTech #MedicalWhitepaper

The anatomy of medical devices and their potential vulnerabilities is complex and concerning. According to the Ponemon Institute, recent research found that almost 50% of connected hospital devices have critical risks and many run on unsupported operating systems. Join us on June 21st at 1 PM ET to hear from our panel of healthcare security experts, who will explore the best of old and new security techniques for medical devices and how to make a shared security responsibility model a reality. Sign Up: https://hubs.ly/Q01Qzzdw0 #cybersecurity #medicaldevices #healthcare #patientsafety #IoMT #webinar

MEDIcept White Paper: Cybersecurity in Medical Devices- Quality System Considerations and Content of Premarket Submissions Are you interested in implementing cybersecurity controls in your medical devices? You’re in luck! This MEDIcept White Paper will discuss all things cybersecurity with a focus on quality system considerations and the content of premarket submissions.  Discover insights into the rapidly evolving landscape of cybersecurity in medical devices with the FDA guidance document, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." In a world where medical devices are becoming increasingly interconnected, this document addresses the imperative need for robust cybersecurity controls, especially with the proliferation of wireless and network-connected capabilities.  Explore the comprehensive approach outlined by the FDA, emphasizing the significance of secure design and mitigation throughout a device's lifecycle. Learn about the groundbreaking Secure Product Development Framework (SPDF) and how the guidance aligns with international recommendations and new cybersecurity requirements introduced by the Consolidated Appropriations Act of 2023. Dive into the future of medical device cybersecurity and stay ahead of the curve in this rapidly evolving field! Click the link below to read the White Paper written by Associate Medical Device Consultant, Trevor Klemann! https://lnkd.in/e452WHTg Do you want to learn more about cybersecurity when it comes to your medical devices? MEDIcept has Quality Engineering experts who are here to help. Reach out to us today at sales@medicept.com.  #cybersecurity #medicaldevices #qualitymanagementsystem #qualityengineering #software

Did you miss our recent Coffee Talk on Use Cases and Cybersecurity for Medical Device Development? Gain invaluable strategies on crafting minimally viable products, engaging stakeholders, scaling solutions effectively, and more! Check out the recording here: https://hubs.li/Q02bpKR70 #MedDev #MedicalDevices #Cybersecurity #Engineering #MedicalProductDevelopment #MedTech

--- 🔥 MedTech Europe position on Cybersecurity 🔥 --- In this position paper, MedTech Europe outlines three key areas of discussion for regulators, medical device manufacturers, healthcare systems and society-at-large. Firstly, that the security of medical technologies continues to be regulated under sectoral legislation. The Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation (‘MDR’ and ‘IVDR’) lay out essential requirements for digital medical technologies and services, including Medical Device Software (MDSW) placed on the EU market. In addition, MDCG 2019-16 rev.1 guidance on cybersecurity, provides medical technology manufacturers with the necessary guidance on fulfilling the relevant General Safety and Performance Requirements of MDR and IVDR respectively, with regards to cybersecurity. It also provides guidance on how to comply with both the Network and Information Security Directive (‘NIS1’), and the General Data Protection Regulation (‘GDPR’), both of which apply to medical technology manufacturers. Secondly, the paper underlines MedTech Europe’s commitment against ransomware, and other malicious interference with healthcare delivery in Europe. MedTech Europe welcomes legislative interventions aimed at reinforcing existing cybersecurity responsibilities and curbing tactics employed by potential cyber-attackers and cyber-criminals. .../... MedTech Europe welcomed the revision of the Network and Information Security Directive (known as ‘NIS2’), as a means of reinforcing the digital resilience of states and businesses, while ensuring that they increase their investments in cybersecurity. While we welcome such legislative intervention, we believe that it should be combined with tangible investments in organisations’ security postures, resilience of digital tools and processes, and the investment in people and the skills necessary to deliver on such legislation. Finally, the paper highlights MedTech Europe’s support for measures aimed at improving the level of overall digital literacy, and particularly, cybersecurity skills. We also applaud the European Commission’s efforts to improve the situation, particularly through the European Skills Agenda Digital Education Action Plan, as well as the recently published communication for a Cybersecurity Skills Academy. " 👇 Do not hesitate contacting me 👇 if you need Regulatory Assistance! Jean-Luc Leneindre. 📧 jleneindre@namsa.com 📞 +33 (0)622 209 153 🌍 https://namsa.com/ #medicaldevices #eumdr #cybersecurity

Save your seat and join Jill Britton and Joe Wrijil as they discuss Cybersecurity Trends for Medical Devices: Vital Insights for Entering 2024. During this webinar, our medical device and standards experts will discuss notable trends across the medical device software development landscape that were highlighted in our 2023 report, Cybersecurity Trends for Medical Devices. https://lnkd.in/g8HmRf7p