Day

September 27, 2018
Partner and General Manager Brian Pate will be one of the faculty for the AAMI Application of Agile Practices course in Arlington, VA USA.  John Murray of FDA is tentatively scheduled to join Brian as faculty.  For more information, send a message below:
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Regulatory Requirements for Software Validation in the Medical Industry
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IEC 80002-1 Software Risk Management for Medical Device and HealthIT
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Effective Application of Agile Practices in the Development of Medical Device Software
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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...
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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...
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