Day

February 19, 2018
FDA made public that the effective date for compliance with the final rule on “Human Subject Protection – Acceptance of Data from Clinical Investigations for Medical Devices.”  According to the announcement from FDA, the “update relates to the standards for accepting clinical data from clinical investigations conducted inside and outside the United States” with the stated...
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IEC 62304 and other Emerging Standards Impacting Medical Device Software

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Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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