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
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email email@example.com for more info.