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MedTech news roundup Summer 2026
Our Summer 2026 MedTech news roundup covers a new MDCG position paper on UDI assignment between manufacturers and distributors, and…
Congenius
EN 18286 | What’s new & what’s the impact?
Last month (July 2026), CEN & CENELEC published the European Standard EN 18286, which defines a QMS specifically to meet…
Congenius
MDR 2.0 & EU AI Act | Implications for AI in MedTech
The Commission’s proposal COM (2025) 1023 final (widely known as MDR 2.0) aims to simplify and streamline the MDR by…
Congenius
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
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