Resource Center
Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.
Sort by topic
Sort by resource type
The COVID-19 pandemic has forced some of the most drastic loosening of regulatory requirements the FDA has ever ...
Bingham Farms, MI, June 23, 2020 –E.M.M.A. International Consulting Group, Inc. (EMMA International), a global ...
As several PPEs, Ventilators, test kits, and other devices have been on the US market for quite some time now ...
When COVID-19 caused the Commission to delay the MDR date of application by a year (May 2021), it was advised that ...
FDA has already issued temporary policies on how it regulates PPEs and various other covid-19 essential medical ...
The EU commission released a guidance document this week that explains the commission’s policies for transitioning ...
The FDA has recently released a new emergency use authorization (EUA) template aimed at developers of at-home ...
COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, was officially declared a pandemic back in early ...
Last week the FDA released a new compliance program for inspections of CDER-led or CDRH-led combination products ...
In light of the COVID-19 pandemic, the EU commission adopted the Regulation (EU) 2020/561 that deferred the ...
Bingham Farms, MI, June 12, 2020 – E.M.M.A. International Consulting Group, Inc. (EMMA International), a ...
As medical device firms adjust to the new normal in light of COVID-19 hurdles, the FDA continues to issue ...
No results found.