6/17/98 Lifescan Surestep Blood Glucose Monitoring System (Meter of home use) Changed to Class I
727,004 units The meters may give an Er 1 (Error 1)message if a patient’s blood glucose is 500 mg/dL or greater.
6/17/98 Lifescan Surestep Blood Glucose Monitoring System (Meter of home use) Changed to Class I
727,004 units The meters may give an Er 1 (Error 1)message if a patient’s blood glucose is 500 mg/dL or greater.
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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