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MedTech news round up February

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

January 2021 has been a busy month for the industry, with updates to standards, new guidance releases and measures taken…

Premarket approval (PMA) is the most stringent type of device marketing application required by the FDA. Find out when a…

This month`s MedTech news round up covers the Brexit impact on clinical studies, EC clarification on remote audits, FDA`s update on Electromagnetic…

What is the difference between a Traditional, Abbreviated and Special 510(k)? In which scenario should you use each submission type?…

As part of our goal to keep our customers informed and up to date, we will now be regularly publishing…

At Congenius we look to provide reassurance through knowledge. In addition to the services we provide our customers, every six…