Daily Writeups
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Daily Writeups
πŸ”–New Writeup❗️
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πŸ—“Date: Sat, 01 Apr 2023 14:30:45 GMT
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✏️Title: Cybersecurity for safeguarding medical equipment is now critical for FDA approval.
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πŸ“ŽLink: https://medium.com/p/b5038cf766bf
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Tags: #hacking #fda #medical_devices #cybersecurity
Medium
Cybersecurity for safeguarding medical equipment is now critical for FDA approval.
In a very important piece of news, the FDA has finally formalized the importance of cybersecurity controls among medical devices by issuing…
2 views
Daily Writeups
πŸ”–New Writeup❗️
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πŸ—“Date: Wed, 05 Apr 2023 16:27:23 GMT
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✏️Title: FDA Cyber Device Guidanceβ€Šβ€”β€ŠThe more you know…
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πŸ“ŽLink: https://medium.com/p/9ddcc751724d
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Tags: #regulation #omnibus_law #medical_devices #fda #cybersecurity
Medium
FDA Cyber Device Guidance β€” The more you know…
Part 1/4 of our FDA Refuse to Accept (RTA)Guidance Series
4 views
Daily Writeups
πŸ”–New Writeup❗️
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πŸ—“Date: Thu, 06 Apr 2023 17:00:02 GMT
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✏️Title: FDA Cyber Device Guidanceβ€Šβ€”β€ŠMonitor and maintain the security of each device for the life of the…
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πŸ“ŽLink: https://medium.com/p/18f13fb5240e
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Tags: #medical_devices #security #fda #healthtech #cybersecurity
Medium
FDA Cyber Device Guidance β€” Monitor and maintain the security of each device for the life of the device
Part 2/4 of our FDA Refuse to Accept (RTA)Guidance Series
4 views
Daily Writeups
πŸ”–New Writeup❗️
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πŸ—“Date: Sat, 08 Apr 2023 00:50:47 GMT
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✏️Title: FDA Cyber Device Guidanceβ€Šβ€”β€ŠGenerate and maintain a software bill of materials (SBOM)
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πŸ“ŽLink: https://medium.com/p/71970fac7a00
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Tags: #medical_devices #sbom #fda #cybersecurity #medtech
Medium
FDA Cyber Device Guidance β€” Generate and maintain a software bill of materials (SBOM)
Part 3/4 of our FDA Refuse to Accept (RTA)Guidance Series
6 views
Daily Writeups
πŸ”–New Writeup❗️
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πŸ—“Date: Mon, 10 Apr 2023 21:55:54 GMT
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✏️Title: FDA Cyber Device Guidanceβ€Šβ€”β€ŠGenerate and maintain requisite documentation proving you’ve done so…
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πŸ“ŽLink: https://medium.com/p/7f43a93bcf07
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Tags: #cybersecurity #medical_devices #fda_approval #fda #medtech
Medium
FDA Cyber Device Guidance β€” Generate and maintain requisite documentation proving you’ve done so as part of your FDA regulatory…
Part 4/4 of our FDA Refuse to Accept (RTA)Guidance Series
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Daily Writeups
πŸ”–New Writeup❗️
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πŸ—“Date: Mon, 17 Apr 2023 23:34:47 GMT
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✏️Title: Building Secure Medical Devices: A High-Level Guide to Cybersecurity
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πŸ“ŽLink: https://medium.com/p/f569ae819a82
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Tags: #medical_devices #cybersecurity #fda
Medium
Building Secure Medical Devices: A High-Level Guide to Cybersecurity
Introduction
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Daily Writeups
πŸ”–New Writeup❗️
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πŸ—“Date: Tue, 29 Aug 2023 18:59:59 GMT
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✏️Title: Prepare for RTA: What is the FDA Medical Device Review Process?
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πŸ“ŽLink: https://medium.com/p/c64d256c22e9
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Tags: #cybersecurity #medical_devices #fda_approval #fda #medtech
Medium
Prepare for RTA: What is the FDA Medical Device Review Process?
By Naomi Schwartz
8 views
Daily Writeups
πŸ”–New Writeup❗️
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πŸ—“Date: Wed, 13 Sep 2023 21:45:13 GMT
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✏️Title: What is eSTAR?
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πŸ“ŽLink: https://medium.com/p/357cf3630cd4
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Tags: #proactive_security #medical_device_regulation #fda #cybersecurity
Medium
What is eSTAR?
In parallel with issuing the RTA guidance, the FDA announced in June 2023 their pilot program for the Electronic Submission Template and…
8 views
Daily Writeups
β€· Title: Navigating Medical Device Cybersecurity: Key Takeaways from Our Ask Me Anything Webinar
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π€ͺ Author: Medcrypt
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β΄΅ Time: Tue, 01 Apr 2025 23:39:05 GMT
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βŒ— Tags: #cybersecurity #healthcare #regulation #medical_devices #fda
Medium
Navigating Medical Device Cybersecurity: Key Takeaways from Our Ask Me Anything Webinar
Medical device cybersecurity is evolving rapidly, and regulatory expectations continue to shift as the threat landscape expands. To help…
17 views
Daily Writeups
β€· Title: Additional risky behaviors in the Contec CMS8000
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π€ͺ Author: Karambit.AI
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β΄΅ Time: Fri, 30 May 2025 00:14:12 GMT
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βŒ— Tags: #patient_safety #sbob #cybersecurity #fda #medical_devices
Medium
Additional risky behaviors in the Contec CMS8000
The β€œbackdoor” mentioned in our previous post is not the only function in the firmware that contains risky behaviors. The code does have…
22 views
Daily Writeups
β€· Title: Apple Watch Series 11 Unveils FDA-Approved Hypertension Alerts
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π€ͺ Author: Ddos
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β΄΅ Time: Mon, 15 Sep 2025 00:03:58 +0000
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βŒ— Tags: #Technology #Apple #Apple Watch #FDA #Health #hypertension #innovation #Smartwatch #Wearable Tech
Daily CyberSecurity
Apple Watch Series 11 Unveils FDA-Approved Hypertension Alerts
7 views
Daily Writeups
β€· Title: FDA Section 524B Penetration Testing and Documentation Services for Medical Device
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π€ͺ Author: QualysecEurope
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β΄΅ Time: Mon, 03 Aug 2026 13:05:48 GMT
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βŒ— Tags: #compliance #penetration_testing #fda #cybersecurity
Medium
FDA Section 524B Penetration Testing and Documentation Services for Medical Device
A submission can begin to unravel with one simple reviewer question: what exactly did you test? Vulnerability tables and severity scores…
7 views