
2022 Scientific Computing Days - Poster Gallery | FDA
Sean Smith, Luis Santana-Quintero, Paul Carlson, Konstantinos Karagiannis: [email protected] (click to watch!) Simulating In-Silico Clinical Research using diverse...
2021 Scientific Computing Days - Posters | FDA
Sean Smith, Michael Colgan, Luis Santana-Quintero, Konstantinos Karagiannis [email protected] HELIX (Hybrid Environment for Longitudinal health Information eXchange) – A multifactor ...
SaMD Cybersecurity Threat Modelling: Understanding the FDA
Feb 25, 2024 · Threat Modeling for SaMD: A Step-by-Step Guide to Compliance with MDR and FDA Regulations, shared by Ivo Flipse. Understanding cybersecurity can be overwhelming for regulatory professionals due...
Clinical Strategy as Part of Pre-submission Dialogue Between ...
Mar 2, 2025 · FDA reprocessing rules for single-use devices, was broken down by Dr. Pallavi Dasgupta. Yujan Shrestha, MD highlighted a potential $1M cost-saving method for AI/ML device ground truthing.
Sean Smith on LinkedIn: #mlv #fda #510k #regulatory #pma # ...
Founder & Publisher | MedTech, Life Sciences, HealthTech | MDR/IVDR, QA/RA | Leading Voice Program | Worker 🐝. Passionate about Regulatory and QMS Compliance in Medical Devices | Expertise in...
The secret plan to save Maine's iconic red hot dogs after ... - WGME
Jan 16, 2025 · The company expected the FDA to eventually ban the ingredient, said Sean Smith, W.A. Bean & Sons’ sales director. Because of this, the business has been exploring ways to make red snappers...
Mouse embryo CoCoPUTs: novel murine transcriptomic-weighted …
Sep 6, 2024 · To better understand the substantial impact of synonymous mutational variations in the cell-state-specific transcriptome on a tissue's codon and codon pair usage landscape, we have established a novel resource-Mouse Embryo Codon and Codon Pair Usage Tables (Mouse Embryo CoCoPUTs).
2024 Scientific Computing Days - Poster Gallery | FDA
Nov 19, 2024 · On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.
Jun 6, 2006 · FDA and industry experts discussed the evolving strategies for selecting and qualifying reference standards for new biotech products and the regulatory implications involved. Reference standard acceptance criteria, formulation and change management are among the challenging issues that drew debate.
Sean Smith on LinkedIn: #fda #presub #510k #medicaldevices # ...
Our latest blog, "Navigating Registration and Listing for FDA Regulated Products," breaks down this essential step in bringing your product to market. We cover everything from understanding...
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