General Safety & Performance Requirements — Risk Analyses Overall System of Trial

Comply-or-die-in MR-science

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Registering Ethics Proposal at BASEC and filling out BASEC project form

Introduction This post ONLY describes how a medical device MR trial proposal can be submitted in Switzerland. In the EU this will different and will depend on the country and local ethics committee rules that apply. The post describes the data that was entered for the SIGNATURES2023 trial, and for your study this will be… Continue reading Registering Ethics Proposal at BASEC and filling out BASEC project form

How to Apply for an Ethics Approval for your MR-research

🇨🇭 How to Apply for an Ethics Approval for Your MR-Research Navigating the ethics approval process for your MR research can be a daunting task, particularly when investigator-initiated trials (IIT) and strict legal compliance are involved. Even after securing funding from organizations like the Swiss National Science Foundation (SNSF) or the EU Commission, the real… Continue reading How to Apply for an Ethics Approval for your MR-research

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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