Author: Johannes Slotboom

EUDAMED: Essentials for MR-scientists

EUDAMED & MR-science Status check for non-CE-marked MR pulse sequences and RF coils used in clinical investigations under EU MDR. Note websites checked last checked at 5 Sep 2025 Source: European Commission “Medical Devices – EUDAMED” latest updates What is EUDAMED and when did it start? EUDAMED is the European Commission’s database for medical devices… Continue reading EUDAMED: Essentials for MR-scientists

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

How to use the IB-creator GPT

You need to be logged in to view this content. Please Log In. Not a Member? Join Us

General Safety & Performance Requirements — Normal and Deuterated-Glucose supplementation related documents

Introduction to Food Supplementation in Clinical Trials Regulatory Considerations for Swissmedic / [or local responsible EU-CA]  and Ethics Proposals Clinical trials involving food supplementation, such as α-D-glucose and 6,6’-d-glucose, require thorough planning and regulatory compliance due to their dual status as food substances and investigational products. While generally recognized as safe under normal dietary circumstances,… Continue reading General Safety & Performance Requirements — Normal and Deuterated-Glucose supplementation related documents

Investigator Brochure Builder-GPT

You need to be logged in to view this content. Please Log In. Not a Member? Join Us

Risk Analysis in MR Medical Device Trials

You need to be logged in to view this content. Please Log In. Not a Member? Join Us

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