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MUSINGS ON MEDICAL DEVICE SOFTWARE
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New FDA Software Guidance - Here We Go Again
Our guest medical device experts this week are the British hair band Whitesnake. Thinking about the new FDA software guidance relative...
erikm67
Nov 6, 20217 min read
3 comments
Read This Book!
Do you remember that Jack Nicholson movie "As Good As It Gets" from the late 90s? Jack tells Helen Hunt "You make me want to be a better...
erikm67
Jun 6, 20213 min read
0 comments
What's Your Country Song aka What's Your Cyber Reference List
Thomas Rhett helps us with medical device software this week. (Not to brag but my cousin in Thomas Rhett's band.) When you're rolling...
erikm67
Apr 4, 20215 min read
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Stronger (What Doesn't Kill You) - The NIST Cybersecurity Framework
Readers of the blog will agree that the last few guest medical device software experts; Muddy Waters, Led Zeppelin, Meatloaf and the...
erikm67
Mar 28, 20214 min read
0 comments
Easter Bunny, Tooth Fairy and Predictable Software Processes
Do you believe in the Easter Bunny? Do you believe in the Tooth Fairy? I believe that *next* year is the year for a championship...
erikm67
Mar 21, 20214 min read
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As the Beatles Sing: Come Together, Right Now for Integration Testing
I am going to say it. In my experience, coming together for integration testing gets little love. In this post I am going to explore...
erikm67
Mar 14, 20213 min read
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Let's Do the Time Warp Again - A Computer Museum
A computer museum opened in my town. (https://www.computermuseumofamerica.org) Literally in my town, Roswell, GA, a few miles from my...
erikm67
Mar 7, 20214 min read
0 comments
Ethical Question in Muddy Waters: Security Reporting as a Weapon
This week I am wrestling with an ethical question. I was contacted by a representative of a security company about doing some business...
erikm67
Feb 28, 20213 min read
0 comments
Avoiding Communication Breakdown
When dealing with connected medical devices in the IOMT (Internet of medical things) world no one wants a communication breakdown...
erikm67
Feb 18, 20213 min read
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New FDA Med Device Cybersecurity Director
Interesting to see that the FDA has created a new acting Director of Medical Device Cybersecurity position, Kevin Fu. U-M professor...
erikm67
Feb 10, 20211 min read
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Monitoring for Vulnerabilities
It is important to regularly monitor for any new cybersecurity vulnerabilities particularly if the software bill of materials (SBOM) for...
erikm67
Feb 8, 20214 min read
1 comment
But wait, there's more! Postmarket Security
Congratulations! You shipped your new software controlled medical device and you built it securely. You did your threat modeling, risk...
erikm67
Feb 1, 20214 min read
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