Over the last ten years, the number of MRI scanners in the world has doubled. This means that during his/her lifetime, a human being can undergo an average of four MRI scans. Besides, there is an increasing variety of medical devices likely to be introduced or used in a MRI environment (surgical implant, active implante, vital-sign monitoring devices, stretchers or wheelchairs).
This is the reason why, when a new medical device is marketted, European notified bodies or foreign certification bodies ask to consider an assessment of the risks related to the introduction of the medical device in a MRI environment.
How to proceed? Our webinar, led by Healtis, LNE’s partner company for these issues, will answer that question:
- Risks related to the introduction of a MD in a MRI environment,
- Regulatory aspects of MRI compatibility,
- Risk assessment, MRI compatibility tests.
Yannick PONVIANNEHealtis’ CEO
Yannick Ponvianne is Healtis’ CEO. Engineer by training, he began his career research laboratories specialised in MRI that today are Healtis’ partners. There, he was managing a national clinical research project on MRI. Then, he joined a young growing medical company as an IT Manager. There, he founded and developed a department, managed important IT development projects and considered quality aspects (ISO 17020). These experiences led him to found Healtis in 2012, together with two researchers specialised in MRI.
HEALTISA company that specialises in MRI Safety
Healtis is a testing laboratory for the assessment of medical device MRI compatibility. Inspired by INSERM research laboratories, Healtis has strong expertise in this field. During its first two years, it assessed the risks related to the introduction of various implantable medical devices (pacemakers, cochlear implants, joint prostheses, etc.) or non-implantable medical devices (monitoring equipment, measuring probes, etc.). Healtis lauched a research and development programme in order to develop its expertise and it is now part of the field’s standardisation work groups.
Healtis also supports its clients and helps them to develop their MRI-related risk assessment or to intervene in the design of MDs that will be introduced in the MRI scanner.