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Which data is sent to the cloud?

by Mauela Escobar Sanz de Santamaria | Mar 3, 2023

All Protected Health Information is removed before the data is sent to the cloud application.

How does MRIguidance deal with information security?

by Mauela Escobar Sanz de Santamaria | Mar 3, 2023

MRIguidance has a high focus on information security. We show that by ensuring our product development complies with international standards on information security, and by ensuring that our whole organisation takes information security in consideration. We have...

Are MRIguidance and BoneMRI compliant with Data Protection Regulations?

by Mauela Escobar Sanz de Santamaria | Mar 3, 2023

Yes. BoneMRI is compliant with all relevant data protection regulations. Further details on how we process data is discussed within Data Processing Agreements that are signed with each customer.

What ISO certifications does MRIguidance have?

by Mauela Escobar Sanz de Santamaria | Mar 3, 2023

MRIguidance holds an ISO 13485 certificate for their Quality Management System and an ISO 27001 certificate for their Information Security Management System. These certificates are available upon request.

Is BoneMRI a certified product?

by Mauela Escobar Sanz de Santamaria | Mar 3, 2023

Yes. BoneMRI is CE certified as a class IIa medical device under the EU Medical Device Regulations. In addition, it is also cleared for use on the US market via FDA 510(k) clearance.

Recent news

  • FDA Clears BoneMRI Lumbar Spine for GE Scanners and Cloud
  • BoneMRI explained: How deep learning is the backbone of our product
  • First successful human spine surgery based on BoneMRI
  • FDA clearance for Lumbar Spine BoneMRI
  • Addie Harris joins the Advisory Board of MRIguidance 

Contact

+31(0)6 – 817 417 11
info@mriguidance.com
Maliesingel 23, 3581 BG
Utrecht, The Netherlands

CE | FDA | ISO 13485 | GDPR | ISO 27001

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