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HEALTIS SAS

5, rue du Morvan, CHRU Nancy Brabois Bâtiment des Adultes, 54500 Vandoeuvre-Les-Nancy
France

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This company is co-exhibitor of
Business France EPIC

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Contact

Yannick Ponvianne

President, CEO

Phone
+33(0)6 30 20 56 06

Email
y.ponvianne@healtis.com

Spencer Parent

Technical Sales Engineer | MRI Test Engineer

Phone
+33 (0)7 49 08 15 78

Email
s.parent@healtis.com

Visit us

Unsettled / NN

16.11.2020

Topic

all-day

MRI Safety and Compatibility Assessment

Are you a medical device manufacturer going through the process of MRI labelling for the first time? 

Do you have a current of upcoming project that requires MRI testing?

Book a time to speak with us today and let us guide you through the process of the MRI testing required to get your product on the market.

Contact us to schedule a free consultation today!

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Our range of products

Product categories

Our products

Product category: Medical device approval, Labeling, Safety testing

MRI safety and compatibility testing

ISO/IEC 17025 accredited* MRI safety & compatibility testing

ASTM Standards (Passive Medical Devices)
ASTM F2052 Measurement of the displacement force generated by the static magnetic field
ASTM F2213 Measurement of the torque generated by the static magnetic field
ASTM F2182 Measurement of the Radio Frequency induced heating
ASTM F2119 Evaluation of the image artifacts generated by the presence of the device
ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment 

ISO / TS 10974 (Active Medical Devices)
Clause 8 Assessment of radiofrequency heating
Clause 9 Assessment of gradient field heating
Clause 10 Evaluation of vibrations
Clause 11 Measurement of the displacement force induced by the static magnetic field
Clause 12 Measurement of the magnetic torque induced by the static magnetic field
Clause 13 Assessment of gradient field induced currents
Clause 14 Assessment of malfunctions due to the static magnetic field
Clause 15 Assessment of radio frequency induced malfunctions
Clause 16 Assessment of gradient field induced malfunctions
Clause 17 Assessment of the combined field effects (possibility to monitor implant activity)
Clause 18 Evaluation of the image artifacts generated by the presence of the device

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

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Product category: Medical device approval, Labeling, Safety testing

Technical and regulatory expertise

HEALTIS is a leader in evaluating the safety of medical devices introduced in the MRI environment. Our experts participate in the development of standards in the field. This allows us to be at the forefront of knowledge in the evaluation of interactions between MRI and medical devices but also to anticipate changes. Benefit from our expertise through our numerous technical and regulatory assistance services. 

Proposed Risk Assessment Strategy
Determination of the worstcases
Writing Rationals
Interpretation of results and marking of the device according to ASTM F2503
Audit of your risk assessment in MRI and proofreading of documents

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Product category: Medical device approval, Labeling, Safety testing

Numerical modeling

Medical devices may experience an increase in temperature as a result of the radio frequencies present during an MRI exam.

Evaluation of this radio frequency heating is a complex subject which can be simplified and assisted by the use of numerical modeling. HEALTIS is expert in this field and can accompany you:

determine worstcases in ranges of passive devices with multiple configurations
determine the points of maximum heating on a device
specific studies requiring the modeling of radiofrequency heating

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Product category: Medical device approval, Labeling, Safety testing

R&D Support

Offering a device compatible with an MRI environment can be a real competitive advantage. For some products it has even become indispensable.

Taking into account the safety aspect in MRI in the design of a product is complex for the manufacturer. This requires skills that are not always available internally: in-depth knowledge of MRI, interactions between electromagnetic waves of MRI and devices, knowledge of material physics and electronics. As experts in the field, our engineers and doctors can guide you during these phases of R & D.This support for R & D can take different forms, which we systematically adapt to your needs. Such as,

  • performing preliminary tests for a first discovery of potential difficulties related to the introduction of your device in MRI or to quickly assess the behavior of a prototype or component
  • assistance in the design of the device to guide you on the choice of components, materials, design recommendations, ….
  • studies by numerical modeling

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Product category: Medical device approval

Training services

Wishing to share our knowledge, our training aims to help you develop skills in assessing the safety of MRI devices. We discuss the technical, scientific and regulatory aspects of the safety and compatibility of medical devices in the MRI environment. Here are some examples of themes we can deal with:

  • the risks generated by the interactions between the Medical Device and the electromagnetic waves of the MRI
  • applicable regulations and test methods for evaluating the safety of a Medical Device in MRI
  • integration of MRI compatibility into product design

These training courses are tailor-made to be adapted to your problem, your products and your level of knowledge.

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Company news

Date

Topic

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Jul 5, 2020

Healtis adds ISO/TS 10974 B0 Malfunction testing and ASTM F2503 MRI Labelling to our catalog of accredited services

Healtis is pleased to announce that we are now able to offer the following accredited services:

B0 Malfunction testing according to ISO/TS 10974 Clause 14 'Assessment of malfunctions due to the static magnetic field'

MRI Labelling according to ASTM F2503 'Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment'

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

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May 13, 2020

Critical Update of Regulatory Standard ASTM F2182

As leaders in MRI safety, Healtis is actively involved in the evolution of the normative standards surrounding the MRI safety and compatibility testing of both passive and active medical devices.

As such, we wanted to inform you of a recent change in the critical ASTM F2182 standard ‘Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging’ . As of this month, this standard has been updated to edition 19e2.

If you currently have a MR conditional product on the market, this change may affect your device. Contact us today to see how your old test report compares to the new requirements of the current edition of the regulatory standard and what actions you may need to take.

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About us

Company details

HEALTIS is a MRI Safety and Compatibility laboratory based in Nancy, France; founded in 2012 by Yannick Ponvianne, Cédric Pasquier and Jacques Felblinger.

Since 2012, HEALTIS has acquired a strong recognition for its experience in the field of medical device safety in MRI, focusing on the quality of its services, customer support and the research and development of new activities.

HEALTIS now offers a range of services for medical device manufacturers who want to evaluate the safety of their products in the MRI environment or design an MRI-compatible device:

  • MRI-compatible device design support
  • Medical Device safety training in an MRI environment, for R & D teams or regulatory affairs
  • Technical and Regulatory Assistance, to define a relevant evaluation strategy for determining and justifying worstcases
  • Numerical modeling for risk assessment or worstcase determination
  • MRI safety and compatibility tests, under ISO17025 accreditation*,
  • Interpretation of test results and assistance in device labelling according to ASTM F2503

Recognizing that our work is important to our customers, Healtis has been committed to a consistent quality policy since its inception; to ensure the reliability of our results for our clients.

Website: www.healtis.com
E-mail: info@healtis.com
Tel: +33(0) 970 405 479 

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

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Company data

Number of employees

1-19

Foundation

2012

Area of business

Services

Company information as a PDF file