Day

July 17, 2018
17
Jul

JAMA Article by FDA Staff – Summary

July 17, 2018
The latest communication from FDA regarding regulation of medical apps notes that mobile medical apps can greatly help patients be proactive and vigilant about their own healthcare.  There has been increased demand for medical apps, and many of the apps depend on high levels of feedback between patients and clinicians.  The FDA wants to regulate...
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17
Jul

Warning Letter – Data integrity

July 17, 2018
Yuki Gosei Kogyo Co., Ltd. Date:7/17/18 Data Integrity Remediation: Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. We strongly recommend that you retain a qualified consultant to assist in your remediation. In response to this letter, provide the...
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IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

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IEC 81001-5-1 Cybersecurity Lifecycle

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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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