Company: Voluntis Date of Enforcement Report: 11/16/2018 Class II: PRODUCT Insulia Diabetes Management Companion Recall Number: Z-0478-2019 REASON The firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The bug could lead from low-impact to high-impact hypoglycemia depending on the circumstances. A new update of Insulia 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: