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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
Ethics, Expectations & Education: What lies ahead for AI in medical devices?
Artificial Intelligence is changing the world. In a MedTech context, it enables a small team to affect many lives. To…
Congenius
The impact of Artificial Intelligence on the medical device industry
The responsible implementation of Artificial Intelligence within MedTech will transform the efficiency of the industry. But which areas within medical…
Congenius
Creativity meets philanthropy – A film that will improve the lives of children in India
At Congenius, we are committed to facilitating healthier lives, be that through our consultancy work in medical devices, or via…
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…
Congenius
Launching Congenius 2.0
After four years of successful business growth, the time had come to take Congenius to the next level. To help…
Congenius
Consultant Spotlight – Carina Rembeck
Introducing our Consultant Spotlights… Our team at Congenius share important commonalities; MedTech expertise, a thirst for knowledge and a love…
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…
Congenius
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