Two webinars will be held for the National Committees of IEC/SC 62A and the Member Bodies of ISO/TC 215, Health Informatics, as well as the Member Bodies of ISO/TC 210, Quality management and corresponding general aspects for medical devices. These webinars are being held to explain the status of the IEC 62304 project. A committee...Read More
Company: Boston Scientific CorporationDate of Enforcement Report 10/3/2018 Class lI: PRODUCT Model 3300 LATITUDE(TM) Programming System Product Usage – The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed...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: