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Tag: RF pulse sequence development
Ethics proposal — The Clinical Investigation Plan (CIP)
Introduction Navigating the bureaucracy behind clinical trials in Switzerland is no small feat. As a researcher preparing the SIGNATURES2023 study, I quickly found that working with both the local Cantonal Ethics Commission (CEC) and Swissmedic / EMA — two independent bodies with their own rules and regulations — requires a level of coordination and compliance that… Continue reading Ethics proposal — The Clinical Investigation Plan (CIP)
General Safety & Performance Requirements — MR-scanner Related
Introduction to General Safety and Performance Requirements (GSPR) For anyone new to medical device trials, understanding General Safety and Performance Requirements (GSPR) is crucial. These requirements form the foundation of regulatory compliance under the European Medical Device Regulation (MDR) and Swissmedic’s / [or local responsible EU-CA] corresponding regulations. GSPR documents are essential in demonstrating that… Continue reading General Safety & Performance Requirements — MR-scanner Related
Background of this Blog: Personal Experience
Thirty years ago, the landscape of MRI research and clinical trials was a very different world compared to the complex regulatory environment we navigate today. Back then, conducting an MR study required little a few A4 page sized proposal submitted to the local ethics committee here in Bern. It was a time when innovation flourished… Continue reading Background of this Blog: Personal Experience
Investigator Brochure Builder-GPT
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Demystifying the Investigator’s Brochure: A Comprehensive Guide to Preclinical Testing, Device Interactions, and Regulatory Compliance for Swissmedic and KEK Submissions
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