Experience with a Continuous Education Program for Clinical, Regulatory and Quality Affairs in Northwestern Switzerland.

The European Medical Device and In-Vitro Diagnostic Medical Device industry is currently facing a highly challenging situation, as applied regulations have changed significantly over the last year. To cope with this, a novel continuing education program for employees from these sectors provides knowledge and hands-on experience in clinical, regulatory and quality affairs. Since 2020 two classes have been successfully completed at the University of Applied Sciences and Arts Northwestern Switzerland: this paper describes the concept and content, the students, and the benefits both for participants and their employers.

A combined computational and experimental approach to assess the transfer function of real pacemaker leads for MR radiofrequency-induced heating.

Objective: To propose and validate a variation of the classic techniques for the estimation of the transfer function (TF) of a real pacemaker (PM) lead.

Methods: The TF of three commercially available PM leads was measured by combining data from experimental measurements and numerical simulations generated by three sources: a) the experimental local SAR at the tip of the PM lead (single measurement point) exposed to a 64 MHz birdcage body coil; b) the experimental current distribution along the PM lead, obtained by directly injecting a 64 MHz signal inside the lead; c) the electric field (E-field) simulated with a computational model of the 64 MHz birdcage body coil adopted in the experimental measurement performed in a). The effect of the lead trajectory on the estimation of the TF was also estimated.

Radio-Frequency Safety Assessment of Stents in Blood Vessels During Magnetic Resonance Imaging.

The purpose of this study was to investigate the need for high-resolution detailed anatomical modeling to correctly estimate radio-frequency (RF) safety during magnetic resonance imaging (MRI). RF-induced heating near metallic implanted devices depends on the electric field tangential to the device ( ). and specific absorption rate (SAR) were analyzed in blood vessels of an anatomical model to understand if a standard gel phantom accurately represents the potential heating in tissues due to passive vascular implants such as stents.

A numerical investigation on the effect of RF coil feed variability on global and local electromagnetic field exposure in human body models at 64 MHz.

Purpose: This study aims to investigate how the positions of the feeding sources of the transmit radiofrequency (RF) coil, field orientation direction with respect to the patient, and patient dimensions affect the global and local electromagnetic exposure in human body models.

Methods: Three RF coil models were implemented, namely a specific two-source (S2) feed and two multisource feed configurations: generic 32-source (G32) and hybrid 16-source (H16). Thirty-two feeding conditions were studied for the S2, whereas two were studied for the G32 and H16.

Effects of tuning conditions on near field of MRI transmit birdcage coil at 64 MHz.

This study investigates how the tuning conditions of a 64 MHz / 1.5 T radio frequency (RF) birdcage coil modeled with an RF circuit and 3D electromagnetic co-simulation affect the electric and magnetic near-field distribution. Four models were implemented with different tuning conditions and difference between numerical results and measurements was evaluated.