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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MedTech news round up February 2021
Our MedTech news for February 2021 covers the EU Commission’s new information on the management of legacy devices and IVDs,…
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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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