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Tag: ClinO-MD
ClinO-MD: The Swiss regulatory framework guiding clinical trials with medical devices.
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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Ethics proposal — The Clinical Investigation Plan (CIP)
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General Safety & Performance Requirements — Risk Analyses Overall System of Trial
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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
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)
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
Lead EC: General and main site’s documents
Essential BASEC Documents for Ultra-High Field MR Projects Discover the key documents required for submitting an in vivo MR project to BASEC/your local EU-CA/[your local EU-CA/ethics committee], focusing on investigations using non-CE-marked RF coils and pulse sequences, not necessarily, at ultra-high field strengths. In the Table below you find all the documents uploaded to BASEC… Continue reading Lead EC: General and main site’s documents
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
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