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Category: Swissmedic Proposal-Related Writing
In this category posts appear which are predominantly related to making Swissmedic proposals and administrative process and communicating with Swissmedic.
Format and instructions of an Investigators’ Brochure (IB)
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How to use the IB-creator GPT
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Build a regulator-ready Clinical Investitor Plan for MRI/MRS trials
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The CIP-creator GPT input yaml file
Detailed Description of CIP-Intake YAML This page explains the CIP-Intake YAML used by the MR-clinical-trial-CIP-Creator GPT to validate your inputs and generate a regulator-aligned Clinical Investigation Plan (CIP) skeleton for CH and/or EU submissions. Download YAML Empty example.yaml file What the YAML is for File rules & formatting Minimal valid example Full scaffold… Continue reading The CIP-creator GPT input yaml file
Welcome to: “Swiss ClinO-MD & EU-MDR — Investigator Initiated Trials in MR-Research”
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”
General Safety & Performance Requirements — 1H/2H-dual tuned RF-coil related
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Research on Investigational Medical Devices in Switzerland: Legal Insights and EU-MDR Context
Switzerland’s regulatory framework for clinical investigations with medical devices, including investigational devices like experimental MR-pulse sequences and non-CE-marked RF coils, is governed by the Ordinance on Clinical Trials with Medical Devices (ClinO-MD). This aligns with the Swiss Human Research Act (HRA) and is influenced by the European Union’s Medical Device Regulation (EU-MDR) to ensure harmonized… Continue reading Research on Investigational Medical Devices in Switzerland: Legal Insights and EU-MDR Context
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
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
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