MRIguidance is ISO 13485 certified

Certification of the quality management system for medical devices is an important step towards global market roll-out.

Utrecht, October 15th, 2019 – In the past half year, MRIguidance has had its quality management system reviewed by the notified body Dare Medical Certifications. Today, the auditors have confirmed the quality system follows all required regulation in order to be certified.

“We have worked very hard for this.” says Roel Raatgever, CEO of MRIguidance, “and importantly not only the quality assurance officer and the management team, but every employee of MRIguidance has been fully committed to achieving this milestone. I am very proud of the progress we have made since the beginning of this year.”

A quality management system is a requirement for market approval of medical devices. With the ISO 13485 certification, a medical device company ensures it complies with regulation in most countries.

Utrecht, February 2026 – MRIguidance has released a new update to BoneMRI, making the solution easier to use across the hospital workflow while expanding compatibility with scanners, systems, and IT environments.

A key feature of the release is new stitching functionality, which allows clinicians to generate combined anatomical regions of e.g. the cervical, thoracic and lumbar spine, into a single, continuous image, providing total spine views. This enables assessment of pathology across multiple spinal regions without switching between image series, which might improve clinical confidence by visualizing anatomical relationships in one comprehensive view, and reduce interpretation time by eliminating manual cross-referencing between sub-regions.

The update also introduces extended compatibility across imaging platforms and infrastructure. BoneMRI now supports pelvic region imaging across the full range of GE, Siemens, and Philips MRI scanners at both 1.5T and 3T. In addition, the software expands support for Enhanced DICOM processing and is now compatible with Windows Server 2025 OS via the MRIguidance Gateway.

These improvements enhance interoperability with MRI scanners and DICOM inputs, simplify coordination with hospital IT departments, and broaden anatomical and vendor coverage to support smoother clinical adoption.

The release also includes additional support and security enhancements.

The latest BoneMRI update benefits radiologists, MR technologists, IT teams, and surgeons, further strengthening BoneMRI’s role in efficient, radiation-free bone imaging across clinical workflows.

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