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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…
Congenius
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
MedTech news roundup May 2026
Our MedTech news for May 2026 covers the new implementing rules from the EU Commission, MedTech Europe’s call for regulatory…
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
MedTech news roundup April 2026
Our MedTech news for April 2026 covers updates on device classification and the expansion of WET devices under the EU…
Congenius
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