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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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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MedTech news round up January 2021
January 2021 has been a busy month for the industry, with updates to standards, new guidance releases and measures taken…
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A guide to the PMA application process
Premarket approval (PMA) is the most stringent type of device marketing application required by the FDA. Find out when a…
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5 learnings from FDA’s new Biocompatibility guidance
In October last year, the FDA published draft guidance regarding the biocompatibility of certain devices that contact intact skin. Our…
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