SpinSafety® conducts independent evaluations of MRI devices’ technical performance, acting as an external assessor independent of both the manufacturer and the operator.
These evaluations are carried out using standard protocols to assess the physical parameters of MRI-SRM systems, employing the SpinSafety® standard test-objects.
Regulatory Context:
MRI-SRM devices are classified as “medical devices” under Article L 665-3 of the French Public Health Code (Official Journal, January 19, 1994) and in accordance with the NF EN 46002 standard.
They are subject to mandatory monitoring requirements for medical devices as set out in Decree 2001-1154 of December 5, 2001.
Consequently, this includes the requirement to perform Quality Control – either internal or external, as defined in Article D 665-5-1 of the Public Health Code.
Quality Procedures:
SpinSafety® performs macroscopic tests to evaluate the performance of MRI devices and their SRM applications under typical clinical usage conditions.
These procedures are standardized, meaning they are applicable to any device type, irrespective of model or technical capabilities.
Test-Objects:
The SpinSafety® test objects (phantoms) required for Quality Assessment and for implementing the evaluation procedures are standardized.
For any further information, please contact our team.
