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October 26, 2021
Company: GE Healthcare, LLC Date of Enforcement Report: 10/27/2021 Class II PRODUCT SIGNA Premier Recall Number: Z-0132-2022 SIGNA Architect Recall Number: Z-0133-2022 SIGNA Pioneer Recall Number: Z-0134-2022 Discovery MR750w 3.0T Recall Number: Z-0135-2022 Discovery MR750 3.0T Recall Number: Z-0136-2022 SIGNA Creator, SIGNA Explorer Recall Number: Z-0137-2022 SIGNA Voyager Recall Number: Z-0138-2022 SIGNA Artist Recall Number:...
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IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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