The article highlights the aspects related to clinical images to be submitted by the applicant and also describes the approach to be applied concerning modifications to medical devices covered by the scope of the guidance.
RegDesk Regulatory Roundup
The article addresses the aspects related to possible image artifacts and the way they should be treated and also describes the approach to be applied when reporting results.
The article provides an overview of the regulatory requirements related to safety in the magnetic resonance environment and highlights the key points to be taken into consideration by medical device manufacturers and other parties involved.
The article highlights the aspects related to certain specific hazards associated with the use of medical devices in the magnetic resonance environment – namely, displacement force and torque.
The article describes the basics of the approach the applicants should follow when selecting a predicate device to demonstrate substantial equivalence.