Company: Mindray DS USA, Inc. dba Mindray North America Date of Enforcement Report 10/24/2018 Class II: PRODUCT Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00 Recall Number: Z-0170-2019 REASON The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The...Read More
FDA issued a draft guidance “Content of Premarket Submissions forManagement of Cybersecurity in Medical Devices” dated 10/17/18. This document contains a some terms(e.g. Cybersecurity Bill of Materal) and concepts (e.g.,Tier 1 and Tier 2 risks) that it is important for Manufacturers to understand and address in premarket submissions. It also includes labeling recommenations for cybersecurity...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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