Are you navigating the complex process of preparing a medical device trial involving MRI scanners? Whether you are targeting approval under the 🇪🇺 EU MDR or 🇨🇠Swiss ClinO-MD, you have found a specialised resource to support your application process.
The EU and CH MR Trial Compliance Solver offers access to regulatory intelligence and AI-enhanced document support tailored to clinical investigations using CE-marked MR systems in combination with investigational hardware and sequences. The aim is to help MR researchers streamline ethics committee and competent authority submissions while meeting legal and safety obligations.
We provide practical guidance, real-world templates, and approved documentation. The library includes example material such as an Investigator Brochure, Clinical Investigation Plan, Risk Analyses, and Monitoring Plan based on a successfully approved trial. These resources are supported by a GPT-AI assistant designed to help interpret and align documentation with the requirements of EU and Swiss competent authorities and ethics committees.
Need to justify the use of a non-CE-marked head coil? Want to prepare a risk management file aligned with ISO 14155 and IEC 60601 standards? The platform can help generate first drafts of these documents based on your study inputs.
Access to the free and paid membership content is created manually. If you would like access, please send us a short email request. Your email address will be used as your login name.
If you want to send us a request for advice or GPT support, please use the following link: