Day

May 13, 2021
The Medical Device Coordination Group (MDCG) published the ‘Guidance on Standardization for Medical Devices’ (MDCG 2021-5) on April 16, 2021. Though none of the information presented is new material, it does provide a consolidated reference point perhaps most useful to those new to the industry. It is comprised of four sections and intended to explain...
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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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