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…
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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…
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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…
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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…
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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…
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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,…
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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…
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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…
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