Day

October 15, 2019
One of the first steps on the marketing pathway for a medical device is to classify your device. As technology and innovation continue to advance, determining how to classify a device can be complex and challenging. This session will provide information on interacting with FDA for device determination and an introduction to Section 513(g) Requests...
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SoftwareCPR Training Courses

ISO13485:2016 ISO 13485 Internal Audit(or) Training Course (Live, 3-day)

IEC 62304 and other Emerging Standards Impacting Medical Device Software (Live, 3-day)

Being Agile & Yet CompliantISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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