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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 ...
In an effort to accelerate the production of tests for COVID-19, FDA released a new guidance document that will ...
Back in March amid the beginning of the COVID-19 pandemic, the FDA announced that in addition to postponing all ...
EMMA International has helped many different clients in industries from Medical Device, Pharmaceuticals, ...
The effects of COVID-19 have been widespread across different parts of the medical device world, but the Digital ...
Back in Mid-March, when the COVID-19 pandemic was starting to take off in the US, the FDA issued a policy that ...
COVID-19 has severely disrupted the medical device supply chain. Device manufacturers are typically not required ...
The COVID-19 pandemic has had a broad and prevalent impact on the FDA and “normal” medical device life as the ...
In Europe, medical devices are regulated under the Directive 93/42/EEC—the “Medical Devices Directive” (MDD) which ...
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