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IVD Special - Software in a Medical Device (SiMD) vs. Software as a Medical Device (SaMD): Understanding Regulatory Differences and Expectations
In our fourth episode of NAMSA's RAQA Café Podcast, our hosts are joined by NAMSA guest speakers, Sonia Lecce (Principal IVD Regulatory Consultant) and Duan Threats (Senior IVD Regulatory Consultant).
During the discussion, Sonia and Duan delve into the differences between SiMD and SaMD for In Vitro Diagnostics (IVD), as well as FDA criteria deemed important during evaluation of safety and effectiveness of IVD software with one or more device functions.
“Things have changed in diagnostics tremendously; they have brought diagnostics to the forefront as a norm rather than an afterthought” – Sonia Lecce (Principal IVD Regulatory Consultant)
Discussion topics include:
- What criteria classify a device as either SiMD or SaMD for IVDs?
- What regulatory agencies are taking the lead on future IVD regulations?
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By NAMSAIn our fourth episode of NAMSA's RAQA Café Podcast, our hosts are joined by NAMSA guest speakers, Sonia Lecce (Principal IVD Regulatory Consultant) and Duan Threats (Senior IVD Regulatory Consultant).
During the discussion, Sonia and Duan delve into the differences between SiMD and SaMD for In Vitro Diagnostics (IVD), as well as FDA criteria deemed important during evaluation of safety and effectiveness of IVD software with one or more device functions.
“Things have changed in diagnostics tremendously; they have brought diagnostics to the forefront as a norm rather than an afterthought” – Sonia Lecce (Principal IVD Regulatory Consultant)
Discussion topics include:
- What criteria classify a device as either SiMD or SaMD for IVDs?
- What regulatory agencies are taking the lead on future IVD regulations?