The changing landscape for FDA EUAs
An Emergency Use Authorisation (EUA) allows the FDA to protect the health of the US public against chemical, biological, radiological,…
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MedTech news round up August 2021
Our August MedTech news covers the latest updates, guidance and position papers from the US & Canada, Europe & Switzerland,…
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MedTech news round up July 2021
Our July MedTech news covers the latest from the EU commission on harmonised standards under MDR, FDA’s recent efforts to…
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MedTech news round up June 2021
Our MedTech news for June 2021 includes an update on the EU-Swiss MRA, the latest guidance documents from the FDA…
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How to determine legitimate FDA approval
Within the medical devices field, you may have come across terms like “FDA registered”, “FDA certified” and “FDA Registration Certificate”.…
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MedTech news round up May 2021
Our May MedTech news includes timely updates from the US and EU, links to recent notable documents from the MDCG…
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MedTech news round up April 2021
Our April MedTech news covers a round up of the latest updates and information from the EU Commission, MDCG, FDA,…
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MedTech news round up March 2021
Our MedTech news for March 2021 covers MDR updates from Europe & the UK, an insightful piece on leveraging real-world evidence in regulatory…
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