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MDSAP – When to join the program

Based on ISO 13485:2016, MDSAP (Medical Device Single Audit Program) is an audit program that allows for a single regulatory…

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

Leah Kidney is one of our valued consultants in Quality. She’s also an ex-Gaelic Football star, keen traveller and aspiring…

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

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

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

Introducing our Consultant Spotlights… Our team at Congenius share important commonalities; MedTech expertise, a thirst for knowledge and a love…