FDA Premarket Exemptions August 2015

FDA issued the document “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements”. The exemptions cover a many types of devices. The document is at the link provided.

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

Or just email training@softwarecpr.com for more info.

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