Day

January 24, 2019
24
Jan

New Approach for Health Canada

January 24, 2019
Health Canada has recently provided a new approach for device approval as outlined in their “Action Plan on Medical Devices: Continuously Improving Safety, Effectiveness and Quality.” Canada classifies medical devices based on their potential risk, with Class I devices being lowest-risk and Class IV devices presenting the highest risk. The collaborative new approach aims to...
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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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