HPC FOR MRI SAFETY, LLC
- High Performance Computing (HPC) using the latest hardware and software (Sim4Life, HFSS, CST, etc).
- We solve medical device MRI safety problems efficiently and fast.
- More than 20 years of regulatory experience (FDA, EU, and China).
- Legal expertise and subject matter expert depositions in law suits related to MRI injuries.
Professional MRI Services
We have a combined experience of more than a century related to Magnetic Resonance Imaging (MRI) safety for Passive and Active Implantable Medical Devices (PIMDs & AIMDs). We also provide services for Partially Inside Partially Outside medical devices (PIPOs), e.g., catheters, and other Medical Devices Attached to the Patient (MDAPs) during MR scanning, e.g., EEG or ECG electrodes.
Regulatory Expertise
Our experts have reviewed and/or put together thousands of regulatory submissions related to MRI safety of AIMDs, PIMDs, PIPOS, and MDAPs.
Scientific Expertise
Together we have published more than 1000 peer-reviewed publications related to PIMDs, AIMDs, PIPOs, MDAPs, and MRI safety in general.
with 50 years of Combined Regulatory experience We Guarantee Approval in the Shortest Time Possible
Dr. Kainz has reviewed more than 1000 MRI safety related submissions to FDA, knows the Agency from the inside, and published hundreds of peer-reviewed publications related to MRI safety of PIMDs, AIMDs, PIPOs, and MDAPs.
Prof. Ji Chen has done groundbreaking work for MRI safety and led hundreds of medical devices successfully through the regulatory and scientific labyrinth toward MR Conditionality of PIMDs, AIMDs, PIPOs, and MDAPs.
Dr. Manuel Murbach has more than 15 years of experience conducting laboratory and clinical investigations in the field of MRI safety. He is the Managing Director of Murbach EM Consulting.
Need MRI Safety Advice Today?
Call or Email us 24/7.
We are dedicated to simplifying your regulatory processes and ensuring that your
medical device achieves MR Conditional labeling with optimal scan efficacy.
Introducing Our Price Match Guarantee
We encourage you to submit your quote for MRI safety testing for our comprehensive review. Our team, comprised of scientific and regulatory experts, will meticulously assess its technical and regulatory completeness. Should it meet the stringent scientific standards and cover all necessary MRI safety test elements, we pledge not only to offer a competitive price but to surpass it, coupled with a faster delivery time. Your satisfaction is paramount, and our commitment is to provide outstanding value and efficiency across all facets of our scientific and regulatory services."
MRI Safety partners
We are collaborating with the TOP experts in MRI safety, computational modeling and simulations, and the regulatory field.
The Department of Electrical & Computer Engineering at the University of Houston is the leading research institute for MR safety and MR compatibility testing of implants, instruments, and medical devices. UH's tests and simulation standards meet the requirements of all notified bodies.
UH tests medical devices, medical implants and instruments with regard to the numerous interactions in MR and corresponding MRI safety and MR compatibility. UH conducts force & torque tests, RF-induced heating tests, and MR image quality. Using standardized testing methods, e.g., ASTM, ISO, and IEC standards, UH evaluates devices, materials, and procedures used for MRI using state-of-the-art test equipment in their laboratory and at clinical MR sites. In addition, comprehensive consulting services are offered for product improvements, and new product development.
CardioMed Device Consultants is an expanding group of professionals with over 100 years of combined experience working in the field of medical device development, evaluation, and review. Many principal members are former employees of the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). They have had integral roles in the review of medical device marketing applications and regulatory submissions, the development of FDA guidance documents, FDA policies, and both U.S. and international voluntary performance standards. They are dynamic individuals with extensive ties throughout CDRH and the medical device industry. Each individual has his/her own area of device expertise; however, their education, experience, and broad knowledge of FDA’s processes and requirements often prove valuable for manufacturers of medical devices intended for other specialty areas.
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ZMT provides all necessary measurement tools for the safety assessment of Active Implantable Medical Devices (AIMDs). ZMT's Medical Implant Test Systems (MITS) and piX system, and test phantoms that are carefullly designed and optimized. The wide range of Tissue Simulating Media (TSM) encompass the essential vehicle to characterize the medical implants in all MRI environments. ZMT's comprehensive simulation platform, Sim4Life, provides a powerful 3D validated biological and anatomical modeling environment for optimizing the effectiveness and performance of medical devices, and discovering potential new treatments. ZMT also provides test systems for validation procedures that support complex requirements with software tools optimized for test and measurement systems. ZMT leverages the combined strength of their expertise, experience, cost-effective solutions, and commitment to long and fruitful client relationships to enhance the client's competitive advantage during the regulatory submission process.
Professional and Successful Interactions with Regulators
From the Regulatory Director of a large medical device company after a successful pre-Sub meeting with the U.S. FDA where we could eliminate unnecessary requests from FDA and achieved a true Least Burdensome approach: "It's a wonderful outcome! This has been the best Pre-Sub meeting we've ever had since I've been at [company]. Thank you to you and your team for the preparation and getting clarifications in the meeting!!”
This true Least Burdensome approach saved the company tens-of-thousands of dollars and many weeks of testing. Of course, without compromising the safety of their device or reducing the efficacy of their MR Conditional labeling.
Contact us today for a free consultation.
