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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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…
Congenius
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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