Sean Smith, Luis Santana-Quintero, Paul Carlson, Konstantinos Karagiannis: [email protected] (click to watch!) Simulating In-Silico Clinical Research using diverse...

Sean Smith, Michael Colgan, Luis Santana-Quintero, Konstantinos Karagiannis [email protected] HELIX (Hybrid Environment for Longitudinal health Information eXchange) – A multifactor ...

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...

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.

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...

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...

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).

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.

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...