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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EU-Swiss MRA latest: How MDR & lack of MRA update affect medical devices trade
Until now, Switzerland and the EU have relied on a specific chapter of the Mutual Recognition Agreement (MRA) for trade…
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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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A guide to 513(g) requests with the FDA
A 513(g) request for information is a means for medical device manufacturers to obtain information about the FDA’s views regarding…
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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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3 steps to Classifying Medical Devices in the US
The process of classifying a medical device in the US involves reviewing the potential regulatory class (I, II or III),…
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3 steps to Classifying Medical Devices in the EU
To classify a medical device in the EU, the intended use needs to be articulated, before defining and categorising the…
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