MRI Safety MRI Safety and Compatibility

2024

ESMRMB MRI Safety Update 2024

MRI safety starts in the design phase!

Before in end of September at the VDE DGBMT Technical Committee Meeting "Medical Technology in MRI", now a good European central meeting point at Barcelona's ESMRMB has shown the continuous interest in MR SAFETY of medical devices. Various assorted presentations about the MR user perspective, MR environmental workflow (Sessions MRI Safety and Emerging Hardware Solutions (Valentina Hartwig https://www.esmrmb2024.org/abstracts-form/posters-e/abstract-data/191ca6f3f7ef62629032901493512b56) and MR Safety Management Anders Tisell, Touko Kaasalainen, Claude Portanier, Oliver Kraff) of the MR site as well as as potential strategies on devices' MR safety of implants and instruments expanded from former ISMRM presented work. For example estimating the induced current in electrodes using B1 field measurements on the MR scanner for the later individual clinical patient situations presented by Chiara Hartmann. Could such strategies help and get safe and fast enough for individual patient situations? Currently in the full MR Conditional envelope counts for critical devices in MRI especially active implants using the ISO 10974 Clause 8 Tiers for proving overall safety under all dedicated "MR Conditional" conditions.

New IEC 62570 (ASTM 2503 out since August 2023), THE Marking practice for items for use in the MRI Environment, is on it way to cover today's existing testing standards to be followed for assessment and/or testing of MR safety according to ASTM and ISO 10974. Further updates coming potentially 2025 with the 3rd Edition (International Standard), new ASTM MR artifact testing method potentially this winter.

And always good to see how advanced medical devices manufacturers show their MR marked items and devices at the industry exhibition using up to date standard's application.

MR safety is more and more moving into the correct direction and place inside the practical use and clinics, and this is very important and good for the MR users and patients!

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Regulatory Affairs Professional Society - RAPS 24

.. and even earlier while making your Regulatory Affairs Planning for shrinking your MR safety R&D, testing and product approval budget by FACTORS

Exhibiting at RAPS24 in Berlin shows the origin of all importance of MR safety regulatory aspects as well as R&D design questions. MRI-STaR and MR:comp supporting over worldwide 50%+ medical device companies since over 20 years with comprehensive Full MR Safety Assessment, including Q-Submission, Technical Questionnaires, Expert Opinions and MR safety and compatibility testing services as well as Regulatory Affairs Management.

Make your medical devices poof for MRI applications - MR Safe or MR Conditional

 

JUST speak to us in the early stage hour of your Regulatory Affairs Planning and Product Development for saving THOUSANDS of units of your dedicated currency that you better spent in marketing and other valuable aspects of your business.

Looking forward to meet with you! Meet us in Berlin or online to start your RA and R&D design phase into the right direction. Let us introduce our patented RF test systems to you. Making feasible device R&D and MR testing directly at your workbench under ISO 17025 accreditation.

Voucher Code for starting towards your MR Conditional goal:info@mrcomp.com

Next educational MR Safety Specialist (MRSS) and MR Safety Expert (MRSE) course: Washington D.C.,Georgetown University, June 13-15, 2024,seminar@mri-star.com

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