What's New MedTech news round up February 25/02/2021 Our February MedTech news round up covers the EU Commission’s new information on the management of legacy devices and IVDs,… Read more
What's New MedTech news round up January 28/01/2021 January 2021 has been a busy month for the industry, with updates to standards, new guidance releases and measures taken… Read more
What's New A guide to the PMA application process 28/01/2021 Premarket approval (PMA) is the most stringent type of device marketing application required by the FDA. Find out when a… Read more
MedTech news MedTech news round up December 21/12/2020 This month`s MedTech news round up covers the Brexit impact on clinical studies, EC clarification on remote audits, FDA`s update on Electromagnetic… Read more
Fact Sheets A guide to 510(k) Premarket Notification 11/12/2020 What is the difference between a Traditional, Abbreviated and Special 510(k)? In which scenario should you use each submission type?… Read more
MedTech news MedTech news round up November 12/11/2020 As part of our goal to keep our customers informed and up to date, we will now be regularly publishing… Read more
Fact Sheets A guide to De Novo registration 26/10/2020 At Congenius we look to provide reassurance through knowledge. In addition to the services we provide our customers, every six… Read more