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EU | New Commission Implementing Regulation (EU) 2023/1194 on Transitional Provisions for Products without an Intended Medical Purpose

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EU | New Commission Implementing Regulation (EU) 2023/1194 on Transitional Provisions for Products without an Intended Medical Purpose2023-06-29T08:51:20+00:00

EU | Commission Guidance on the Content and Structure of the Summary of the Clinical Investigation Report

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EU | Commission Guidance on the Content and Structure of the Summary of the Clinical Investigation Report2023-06-29T08:40:11+00:00

EU | Substantial modification Documents for Performance Studies under Regulation (EU) 2017/746

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EU | Substantial modification Documents for Performance Studies under Regulation (EU) 2017/7462023-01-06T12:30:40+00:00

EU | Performance Study Application/Notification Documents Under Regulation (EU) 2017/746

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EU | Performance Study Application/Notification Documents Under Regulation (EU) 2017/7462023-01-06T12:23:40+00:00

USA | New FDA Guidance on the Content of Human Factors (Usability) Information in Medical Device Marketing Submissions

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USA | New FDA Guidance on the Content of Human Factors (Usability) Information in Medical Device Marketing Submissions2022-12-17T09:39:22+00:00
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