J. David Giese’s Post

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Medtech Software Dev | Cybersecurity | AI/ML | US Regulatory

Are you considering pushing a 🙊LLM, 🙉LAM, 🙈LMM, or any large 💡 model through the FDA? This could save you trouble. We did a presub for a device that uses LLMs to detect contrast in the DICOM header info. How to FDA Approve LLMs. Step 1 Presubmission. https://hubs.li/Q02w3Qp70

How to FDA Approve LLMs. Step 1 Presubmission.

How to FDA Approve LLMs. Step 1 Presubmission.

hub.innolitics.com

Acacia Parks PhD, MBA

I solve clinical, scientific and regulatory problems

7mo

Thank you for posting this!

Vicky Valla, Ph.D.

Regulatory Affairs & Intelligence | Market Access | Strategic Planning for MedTech & Pharma

7mo

Thank you for sharing this J. David Giese ! As always, when used properly, PreSub turns into a valuable tool

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