COURSE DATES: June 4 – 6, 2019 TRAINING LOCATION: Boston, MA USA COST: 3 Full Days for $2,495.00 Limited number of “Early Bird” Discounted seats: $1,795.00 Registration link Only a limited number of discounted seats are available. For more information on the course, use the form below. This three-day course provides a clear understanding of...Read More
The Verily Study Watch is a device worn on the wrist that digitizes patient physiologic measurements and processes the raw data through algorithms both on the wrist worn device and additional processing when communicated to cloud based computing systems. The idea is that the Verily watch would be worn similar (or as!) a consumer device...Read More
Here are some thoughts from a recent conversation between Sherman Eagles, Brian Pate, and Alan Kusinitz of SoftwareCPR®: Cybersecurity vulnerabilities can have unpredictable effects on safety. Unpredictable effects … to those who have worked to reduce risks of software failures in medical device software, that phrase may be familiar. That concept is explained in relation to...Read More
“IEC TR 80002-1 Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software” has been released. This standard was based on AAMI TIR32 but focuses on the 14971 perspective. AAMI has adopted TR 80002-1 as well and may obsolete TIR32 although there are some areas where TIR32 is...Read More
Schedule Discussion with John F. Murray, Jr.
John is currently providing telephone and face-to-face meetings to discuss: Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.
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