Medical Design & Outsourcing: FDA issues FAQ on 3D-printed equipment against coronavirus

Earlier today Medical Design & Outsourcing published the following from the FDA regarding 3D printed equipment intended to supplement PPE needs created by the ongoing COVID-19 pandemic. “University research teams and others have been racing to develop DIY ventilators to help patients whose breathing is restricted by COVID-19. Those seeking to 3D-print accessories or parts…

Breakthrough Initiative Addresses Shortage of Personal Protective Equipment for Nation’s Healthcare Workers in Wake of COVID-19 Pandemic

Research Collaboration to Allow Manufacturers to 3D Print Thousands of Face Shields in the Coming Weeks    Atlanta, GA – March 24, 2020 – Global Center for Medical Innovation (GCMI), the Southeast’s first and only comprehensive medical device innovation center, today announced a collaboration that addresses the severe shortage of personal protective equipment (PPE) for…

The most expensive study is one you have to repeat. 10 things to know before you start your GLP study.

Good laboratory practice (GLP) studies are an essential component to medical product development and regulatory submissions. They are highly rigorous, are conducted in compliance with a  legally bound code of federal regulations (21 CFR Part 58) and should be conducted by qualified scientists and staff of an accredited contract research organization (CRO). They are also…