FDA’s 2009 pre market submission user fees are posted at http://edocket.access.gpo.gov/2008/pdf/E8-17739.pdf. Note that fees have been added for 513(g) requests for classification. These are often used for getting feedback on software products as to their regulatory classification and status.
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
Or just email training@softwarecpr.com for more info.
