Navigating the world of clinical trial compliance can feel like a journey through a bureaucratic labyrinth, or worse, a modern-day compliance inquisition. When I set out to write my combined Swissmedic and ethics proposals for a research study in MRI, I knew it would be challenging. But nothing prepared me for the sheer scale of… Continue reading Welcome to: “Swiss ClinO-MD & EU-MDR — Investigator Initiated Trials in MR-Research”
Category: Context and personal experiences
In this category posts are located that define a context for the blog and personal experiences.
How to Apply for a Swissmedic Approval for your MR-research
🇨🇭 How to Apply for a Swissmedic Approval of your MR-Research in Switzerland This guide explains the process to obtain authorization from Swissmedic for conducting research involving MR systems (such as high-field MRI) classified as medical devices (MD) in Switzerland. A similar framework also applies within the EU under the Medical Device Regulation (MDR). 🇪🇺🇨🇭… Continue reading How to Apply for a Swissmedic Approval for your MR-research
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
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