Medcrypt

Navigating the complexities of Software as a Medical Device (#SaMD) cybersecurity can be overwhelming. Our latest blog post takes look at some of the most common myths surrounding SaMD #cybersecurity. Whether you’re concerned about meeting FDA requirements or just trying to keep up with best practices, we’ve got you covered. In this blog, we discuss: - Why relying on traditional security measures might not be enough - Common gaps in SaMD cybersecurity that you can address today - Practical tips to help you safeguard patient safety and stay compliant Read more: https://lnkd.in/giYzuViZ

The FDA released new draft guidance on August 22, 2024 on Predetermined Change Control Plans (PCCPs) for Medical Devices. It outlines a policy for PCCPs and provides recommendations on the details to include in a PCCP when submitting a marketing application for a medical device. What does this mean for medical device manufacturers? Read the insight from Medcrypt's VP Services Naomi Schwartz below to find out. The recommendations apply to devices, including device-led combination products, reviewed through the 510(k), De Novo, and PMA pathways. See the draft guidance: https://lnkd.in/gz_6JyPw #FDAguidance #medicaldevices #cybersecurity #PCCPs

Calling all Health-ISAC members! Om Mahida is presenting at the August Monthly Threat Brief this week on August 27 and August 28. Listen in to hear Om dive into a recent vulnerability threat impacting the #healthcare industry. Learn more: https://lnkd.in/eaBBhUMa

Tomorrow, Naomi Schwartz will be J o e H a g e's featured #MedicalDevices #MDGpremium guest on August 23, 2024 at 8:00 a.m. PT. Naomi will be discussing “CrowdStrike's Outage: Medical Device Impact” with listeners. Click here to join the free session: https://medgroup.biz/calls. #cybersecuritywebinar #crowdstrike #medtech

Tomorrow, join Greg Garcia, HSCC Executive Director, in this webinar hosted by Medcrypt and MedISAO. Get an overview of the work done by HSCC, review some specific examples of resources produced by working groups, and discuss HSCC’s recently announced 5-year strategic plan. Register here: https://lnkd.in/gZ6XUr2p

For medical device manufacturers, Helm outperforms SBOM and vulnerability management platforms, including open source tools. Read how Ypsomed AG found success with Helm. Find the right Medcrypt package for your organization. Secure your medical devices, meet regulations, and get to market. Visit medcrypt.com/pricing to explore how you can bundle Helm with Medcrypt's soutions to meet FDA guidance. #CustomerConfidence #FDAguidance #medicaldevicecybersecurity #cybersecuritysolutions

Cybersecurity risks facing radiology practices and imaging centers are often over-looked. Increasing digitization of #medicalimaging means protecting patient data is more critical than ever. From understanding the unique vulnerabilities in #radiology networks to implementing robust #cybersecurity measures, we explore the steps you can take to safeguard sensitive information and reduce risk exposure. Read the blog here: https://lnkd.in/gv3XF2Ut

We hope everyone attending #DEFCON32 and the Biohacking Village are having a great time this week. Medcrypt engineer Daniel Beard is representing and presenting to attendees. Check out Medcrypt's offering for #biohackingvillage attendees: https://lnkd.in/eE8ihNQb Email [email protected] to get started. #DEFCON #biotech #medtech #medicaldevices

Join the upcoming webinar to learn how the Health Sector Coordinating Council (HSCC) can enhance your organization's cybersecurity strategy. The healthcare sector is designated as critical infrastructure, and HSCC plays a vital role in identifying systemic cybersecurity threats, collaborating on risk mitigation, and promoting threat preparedness and incident response. Join Greg Garcia, HSCC Executive Director, on August 20th at 11:00 AM PT/2:00 PM ET. Register here: https://lnkd.in/gZ6XUr2p

Not sure where to find the right solutions for your medical device cybersecurity strategy? Learn how iota Biosciences, Inc. powered by Astellas successfully submitted to the FDA using Medcrypt's services. Discover which Medcrypt package fits your organization. Plan your medical device cybersecurity strategy, meet regulatory requirements, and get your medical devices to market. Visit medcrypt.com/pricing to get started. #FDAguidance #medicaldevicecybersecurity #cybersecuritysolutions #medtech