Medical Products Supplies Companies

5, rue du Morvan CHRU de Nancy Brabois, 54500 Vandoeuvre-lès-Nancy
France
Telephone +33 9 70405479
info@healtis.com
http://www.healtis.com

Product Categories

Product categories

03 Services
03.09 Testing services
03.09.04 Safety testing

Safety testing

Our products

Product category: Safety testing
MRI safety and compatibility testing
We evaluate the MRI safety and compatibility of your devices according to the latest international standards.

According to your needs and skills, our offer can be « turnkey » oriented or « custom-made » :

Turnkey » offer: We will take on everything, from the draft of the testing protocols to the support after the submission of a FDA dossier;
Custom-made » offer: you have in house MRI skills and wish to benefits from our expertise on specific topics.

Our services are structured according to ISO 17025. We guarantee high reactivity from our team, planning of our service and a regular reporting of your projects. And this is done while remaining completely confidential.

According to its quality policy, Healtis undertake to respect the recommendations and the international standards.

International standards for passive implantable medical devices :

Measurement of magnetically induced displacement force in the static magnetic field: ASTM F2052
Measurement of magnetically induced torque in the static magnetic field: ASTM F2213,
Measurement of radio frequency induced heating on the device: ASTM F2182.
Evaluation of image artifacts (according to ASTM F2119), with artifacts surface measurement.
Device marking : ASTM F2503.

International standards for active implantable medical devices :
ISO/TS 10974.

Product category: Safety testing
R&D support
MRI involves complex and demanding physical phenomena. Designing a device compatible with MRI can be long and expensive.

The assistance of an expert Healtis allows you to focus on your skills and become more effective in your development.

Healtis helps you to :

define the product and the use case scenarios,
choose of technologies employed,
do the mechanical design (material selection, design, …),
design the electronic (component selection, routing, …),
and to achieve of adequate pre-testing of sub-assemblies or prototypes.

Product category: Safety testing
Our trainings
For the moment MRI safety has been examined too lightly. To prevent any incident, we offer trainings for your personnel.

Our trainings, delivered by our experts, are intended to anyone who may enter the MRI environment (healthcare personnel, maintenance technicians, firemen, cleaning agents, MRI radiographers…).

Held at your business place or in our offices , each course can be supplemented with practical work on the MRI systems.

Available trainings :

Training about MRI compatibility of the medical devices – Regulatory aspects. Profile concerned: Head of the regulatory affairs of the medical devices.
Training about MRI compatibility of the medical devices – technical aspects. Profile concerned: R&D teams working on medical devices.
Awareness of the MRI environment and its risks. Profile concerned: every profile
MRI safety in everyday’s life. Profile concerned : maintenance technicians, MRI radiographer, radiologists, researchers, firemen…

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About Us

Company details
Healtis is a company based in Nancy (France) and specialized in MRI Safety of both patients and personnel who are working within the MRI environment.

We especially implement our skills in:

Determining the interactions between the MRI systems and the medical devices by MRI compatibility testings;
Assisting designers of medical devices during the product development phases;
Training the personnel about safety in a MRI environment.

The founders
The company was founded in 2012 by Yannick Ponvianne (its CEO), Cédric Pasquier and Jacques Felblinger, respectively researcher and Director in the IADI (INSERM U947) and CIC-IT (INSERM CIT801), french MRI dedicated research laboratories.

Our values / quality policy
Expertise, Innovation, Quality, Respect of commitments and Communication are the key words of Healtis. Daily, these values are implemented to achieve our main goal: the satisfaction of each of our clients.

HEALTIS is ISO/IEC 17025 accredited for its testing services (accreditation N° 1-6320, scope available on www.cofrac.fr).

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