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The UDI Rule requires a device to bear a UDI on its label and packages. Special labeling requirements apply to ...
Last week, the FDA finalized guidance for medical device establishment inspections, which satisfies a requirement ...
FDA released a guidance document on Monday in the form of a question and answer format to help the industry ...
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 ...
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