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The International Medical Device Regulators Forum (IMDRF) has recently issued a final guidance document to outline ...
Back in May, the FDA announced its intention to re-start domestic routine inspections (which you can read more ...
The EU Commission committed to provide information on the availability and the capacity of the notified bodies to ...
The medical device industry is constantly looking for innovative new ways to treat and cure conditions. Last month,
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 under
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 ...
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