April 24, 2019
Company: Gyrus ACMI, Inc. Date of Enforcement Report: 4/24/2019 Class II: PRODUCT Olympus Diego Elite Console MDCONS 100; Recall Number: Z-1178-2019 Part No BB2000SA; Recall Number: Z-1179-2019 Part Number: BB4000SS; Recall Number: Z-1180-2019 Part No: BB4000SC; Recall Number: Z-1181-2019 Product Number:BB4040SS; Recall Number: Z-1182-2019 Product Number: BB4040SC; Recall Number: Z-1183-2019 Product Number: BB4040XS; Recall Number:...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 4/24/2019 Class II: PRODUCT syngo Lab Data Manager System – Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with pre-analytic and post-analytic functions. It works in conjunction with multiple instruments, the laboratory information system (LIS) and the Siemens Healthcare...
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Company: Topcon Medical Systems, Inc. Date of Enforcement Report: 4/24/2019 Class II: PRODUCT IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices without controlling or altering the functions...
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Company: Brainlab AG Date of Enforcement Report: 4/24/2019 Class I: PRODUCT Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. Recall Number: Z-1082-2019 REASON...
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SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

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  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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