How to overcome the CAPA flood
The goal of a CAPA (Corrective and Preventive Action) is to solve a problem or issue. When this goal is…
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MedTech news roundup June 2026
Brought to you by our Head of Regulatory Richie Christian, our June 2026 MedTech news roundup covers the latest on…
Congenius
MDR 2.0 proposal | Key implications for Clinical Affairs
The EU Commission’s proposal COM (2025) 1023 final – widely referred to within the medical device industry as MDR 2.0,…
Congenius
Congenius welcomes Richie Christian as new Head of Regulatory
We are very pleased to welcome our new Head of Regulatory to the Congenius team! Richie Christian joins Congenius with…
Congenius
From Pre-Seed to Exit: The Essential Playbook for MedTech Start-Ups
The journey of building a MedTech start-up is both complex and full of opportunity. From the first idea to clinical…
Congenius
Overcoming the regulatory challenges to achieve global market access
Global regulatory requirements for medical devices differ widely in scope and interpretation. These disparities can delay product launches, elevate compliance…
Congenius
AI Index Report 2026 | Key takeaways
The ninth edition of the AI Index Report has been released – and for the first time, it features standalone…
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Celebrating 10 years of courage, commitment, & culture
This year marks a special milestone for Congenius, as we celebrate our 10-year anniversary. Reflecting on the journey taken this…
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