Company: Medtronic, Inc. Date of Enforcement Report: 1/17/2019 Class I: PRODUCT Medtronic’s Dual Chamber Implantable Pulse Generators (IPGs) are implanted cardiac pacemakers used to provide stimulation to increase heart rate in patients with a slow heart rhythm (bradycardia) or no heart rhythm. The pulse generator is the small implanted unit containing the battery and other...Read More
The West Australian reported that two autonomous haulage systems (AHS) trucks experienced a collision when one of the trucks backed into the cab of the second truck that was stationary at the time. This is of interest to us as the AHS trucks are software controlled and they crashed. Clearly a failure mode. The initial report 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.
Leave a message and we will contact you to schedule: