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MRI/MRS Clinical Trial Compliance Solver

Writing appropriate documents for Competent Agencies in EU and CH for compliant MR-research

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Context and personal experiences
In this category posts are located that define a context for the blog and personal experiences.
Legal Background
In this category posts on the legal situation in ClinO-MD of Switzerland and the EU-MDR are located.
Ethics Proposal-Related Writing
In this category posts appear which are predominantly related to making and registering ethics proposals at local ethics committees.
Swissmedic Proposal-Related Writing
In this category posts appear which are predominantly related to making Swissmedic proposals and administrative process and communicating with Swissmedic.
Practical Help (GPT Access)
In this category prescription related posts and active links to a GPT which developed with the aim to assist MR-scientists in quickly drafting required documents for Swissmedic and ethics committees.
Open AI Powered Document Generation
Regulatory & MR-MD-Trial Abbreviations (EU,CH)
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EU-MDR & MR Clinical Trials Germany
Technical Documentation relevant for Annex I GSPR compliance
EU-MDR & MR Clinical Trials in France
EU-MDR & MR Clinical Trials The Netherlands
EU-MDR & MR Clinical Trials Italy
EU-MDR & MR Clinical Trials Spain
EU Map
EU-MDR & MR Clinical Trials Portugal
EU-MDR & MR Clinical Trials Belgium
EU-MDR & MR Clinical Trials Luxembourg
EU-MDR & MR Clinical Trials Ireland
EU-MDR & MR Clinical Trials Denmark
EU-MDR & MR Clinical Trials Sweden
EU-MDR & MR Clinical Trials Finland
EU-MDR & MR Clinical Trials Estonia
EU-MDR & MR Clinical Trials Latvia
EU-MDR & MR Clinical Trials Lithuania
EU-MDR & MR Clinical Trials Poland
EU-MDR & MR Clinical Trials Czechia
EU-MDR & MR Clinical Trials Slovakia
EU-MDR & MR Clinical Trials Austria
EU-MDR & MR Clinical Trials Hungary
EU-MDR & MR Clinical Trials Slovenia
EU-MDR & MR Clinical Trials Croatia
EU-MDR & MR Clinical Trials Romania
EU-MDR & MR Clinical Trials Bulgaria
EU-MDR & MR Clinical Trials Greece
EU-MDR & MR Clinical Trials Malta
EU-MDR & MR Clinical Trials Cyprus
GSPR of a non CE-marked RF-coil
RF-Pulse Sequence Safety
Overview for MR Trials in the EU using Non-CE marked RF Coils and/or Pulse Sequences
ClinO-MD in CH
How to start a new CA and CEC Proposal?
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MRI/MRS Clinical Trial Compliance Solver

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