FDA Law Blog

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law Blog

MAY 27, 2024

She also specializes in medical device software and digital health. Jennifer’s return adds depth and breadth to our device practice and her strong relationships from her earlier time at the firm has made for a seamless reentry,” said J.P. Ellison, Managing Director at HPM.

Manufacturing 59

Manufacturing Management Utilities Relationship 59

GeriPal

MAY 8, 2025

So in our trial, because of security reasons, we are required by Health Canada to store the substance in a special secure area in my office. Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? James 01:34 Yeah, right on.

Illness 109

Illness IT Patient-Centered Patients 109

GeriPal

DECEMBER 7, 2023

I actually wonder though, since we’re on a GeriPal broadcast, I think that people are under emphasizing the special risk of older people. And so if we think of that relationship though, as these kinds of disasters increasing, so flooding, hurricanes, extreme heat and extreme cold, there are system level things to do.

Healthcare 130

Healthcare IT Education Community 130