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.
DI. Gregor Schaefers 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.
High Performance Computing
We use the latest technology in hardware and software, including GPU accelerated servers and the latest software tools.Regulatory Submission
Putting together a "deficiency free" submission is an art by itself. We are the experts to be able to improve your submissions to minimize deficiencies and delays.Improved MRI Safety
Too hot? We have solutions ready to be implemented to ensure your patients get the MR scan they need. If we don't have it readily available, we will develop a custom made MR safety solution for your device.Advisory Services
Full support from the design phase to the regulatory submission. We know MRI safety.Computational Modeling & Simulations (CM&S)
Verified, validated, and certain. Uncertainty, one of the least understood fields in engineering, is our passion.MRI Safety Experience
Together we can rely on an unparalleled pool of scientific and regulatory expertise. At FDA Dr. Kainz reviewed more than 1000 MR safety related submissionsm, initiated the NIH SPARC Program funded (developed by IT'IS) online platform oSPARC, and developed widely used anatomically correct models of the human anatomy, called the Virtual Family and the MIDA head model.
Comprehensive MRI Safety Strategy
PIMDs
Often Passive Implantable Medical Devices (PIMDs) show high heating using standardized in-vitro measurement methods.
- Sophisticated In-Vitro to In-Vivo Conversion.
- ASTM 2182-19e2.
- The Virtual Family.
- The MIDA Head Model.
- High Precision Measurements.
- Thorough Uncertainty Assessment.
AIMDs
Active Implantable Medical Devices (AIMDs) pose a significant risk to patients if not scientifically correct and soundly tested.
- Founding Member of ISO 10974.
- MDDT (Medical Device Development Tools).
- Tier 1, 2, 3, and Tier 4 Simulations.
- Scientifically Sound Electromagnetic (EM), Thermal, and Mechanical Simulations.
- Verified & Validated (V&V), Certainty.
- Regulatory Grade V&V and Uncertainty Assessment.
Need MRI Safety Advice Today?
Call or Email us 24/7.
We are here to make your life easier and your medical device MR Conditional.
MRI Safety partners
We are collaborating with the TOP experts in MRI safety, computational modeling and simulations, and the regulatory field.
MR:comp is the leading company for MR safety and MR compatibility testing of implants, instruments, and medical devices. As an accredited laboratory (ISO 17025), our tests and simulation standards meet the requirements of all notified bodies.
MR:comp tests medical devices, medical implants and instruments with regard to the numerous interactions in MR and corresponding MRI safety and MR compatibility. MR:comp conducts tests of radiopacity, B0 homogeneity, lumen visibility, MR image quality, and manufacturer MR certificate testing. Using standardized testing methods (e.g., ASTM, ISO, and IEC standards) MR:comp 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, new product development, and personnel training.
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.
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.