About MR Trial Compliance Solver
Welcome to MR Trial Compliance Solver – a project born out of what felt like an eternity of frustration in trying to secure Competent Authority (CA) approval for a magnetic resonance (MR) study in Switzerland.
As many of you working in MR research know, navigating regulatory pathways can be a gruelling experience. The Swiss medical device laws (MedDO and ClinO-MD) are very closely aligned to the EU MDR, and you also have to respect IEC standards, ISO 14155, GDPR (or the FADP in Switzerland), and countless smaller directives. This means that much of the content on this website will hopefully also be useful – at least in first order – throughout the EU and Switzerland.
Why this website exists
Honestly, this site started more out of sheer exasperation and anger than from any entrepreneurial spirit. After losing countless hours to figuring out how to get a CA approval for MR research, I thought it might help if I documented most essential knowledge so that other peer MR scientists might be spared from the same regulatory inferno.
The goal was never to create a glossy too commercial platform. Instead, I aimed to keep it as lean and to-the-point as possible, so that you as peer MR-researchers, wouldn’t spend more time on it than strictly necessary. That said, maintaining this site, covering hosting costs, and paying for access to dedicated GPT tools from OpenAI does mean there are some fees involved.
On consultancy and using GPTs
So while the information provided here is free for you to browse and use as-is, please note:
- It is explicitly not claimed that all information on this site is complete and/or correct. I report on what actually worked for my project involving non CE-marked RF-hardware, non CE-marked pulse sequences, and supplementation of deuterated glucose; quite the worst one can think of, in regulatory terms. However, regulations change, and it remains your own responsibility to check local laws and requirements.
- If you decide to reach out for direct consultancy or if I provide you with access to GPTs for tailored document creation, that will involve fees. Not because I’m chasing huge profit, but to simply cover the expenses for maintaining the site and paying for specialised AI tools and my working time I invest in consultancy requests.
Get in touch
If you’d like to discuss your MR device study plans, have regulatory questions, or simply want to compare notes about how terrible it all is, feel free to reach out.
Email: info@mr-trial-compliance-solver.eu
Phone: +41-77-4028494
Thanks for visiting
I truly hope this site saves you some headaches, or at least gives you a roadmap that’s clearer than the one I had to work with. If it does – that alone makes the effort worthwhile.
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