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Accelerate market entry with AI-powered dossier compilation and local representation, all for a flat annual fee. Starting at $2,000 USD per year for the first device (excludes government fees). Includes dossier submission, in-country representation, translation, modifications, distributor authorization, and post-market support.

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EU Harmonized Standards 2026 Update: Decision (EU) 2026/1231
EU Harmonized Standards 2026 Update: Decision (EU) 2026/1231
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The European Commission has published Implementing Decision (EU) 2026/1231, updating the list of harmonized standards across several medical device areas. Manufacturers should review technical documentation, declarations, test documentation, and internal standards registers against the revised list.

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Vaishna Upendran

Vaishna Upendran writes on project execution, medical device market access, and IVD regulatory coordination for Pure Global.

Project ManagerSweden / Europe1 article
Vaishna Upendran
Vaishna Upendran
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About Vaishna Upendran

Vaishna Upendran writes on project execution, medical device market access, and IVD regulatory coordination for Pure Global.

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