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March 19, 2024
Company: Philips Respironics, Inc. Date of Enforcement Report: March 19, 2024 Class I PRODUCT Trilogy EVO, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal Recall Number: Z-1502-2024 REASON: Philips Respironics, Inc. has notified customers to update to the latest software version (1.05.06.00) of its Trilogy Evo continuous ventilator devices due to a possible power...
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SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

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