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?…
Congenius
MedTech news round up November 2020
As part of our goal to keep our customers informed and up to date, we will now be regularly publishing…
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A guide to De Novo registration
At Congenius we look to provide reassurance through knowledge. In addition to the services we provide our customers, every six…
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