by Chad Brueck | Oct 6, 2023 | MDC Blog
Every October, the FDA’s registration and listing window opens, and medical devices of all shapes, sizes, colors, and claims manage to list themselves, effortlessly finding their special place in the agency’s registration and listing database for the next twelve...
by Chad Brueck | Sep 30, 2023 | MDC Blog
It was not quite the 11th hour, but close to it. A compromise was reached on a short-term stopgap bill to continue funding the U.S. government. Unfortunately, this only buys a little time, providing funding through the 17th of November 2023. We are monitoring the...
by Chad Brueck | Aug 16, 2023 | MDC Blog
Have you obtained EUA for your U.S. product? Are you grappling with the ever-shifting landscape of quality and regulations? Brace yourself as the tides are turning again. Companies that have received EUA were not required to have complete quality system controls. The...
by Chad Brueck | Jun 30, 2023 | MDC Blog
Connect, train, and empower a community of practice OneLab TEST aims to connect, train, and empower a community of practice among professionals and volunteers who perform or coordinate testing at non-laboratory sites. Ultimately, OneLab TEST will strengthen...
by Chad Brueck | Apr 24, 2022 | MDC Blog
Healthcare as we enjoy it today would be impossible without them. Often referred to as a hidden profession, these vital detectives of the healthcare field make modern medicine possible at the exacting standards we’ve become accustomed to. Please join us in honoring...
by Chad Brueck | Jul 23, 2021 | MDC Blog
Are you ready for IVDR Enforcement? We’re entering the final stretch, leading to the defining moment we’ve all anticipated for over four years at this point. No, it’s not Brexit. May 27, 2022, is the first day European authorities are fully within their rights to...
