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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MedTech news round up December 2020
Our December 2020 MedTech news round up covers the Brexit impact on clinical studies, EC clarification on remote audits, FDA`s update on…
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A guide to 510(k) Premarket Notification
What is the difference between a Traditional, Abbreviated and Special 510(k)? In which scenario should you use each submission type?…
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