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).
Professional MRI Services
with 50 years of Combined Regulatory experience We Guarantee Approval in the Shortest Time Possible
High Performance ComputingWe use the latest technology in hardware and software, including GPU accelerated servers and the latest software tools.
Regulatory SubmissionPutting 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 SafetyToo 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 ServicesFull 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 ExperienceTogether 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
- Sophisticated In-Vitro to In-Vivo Conversion
- ASTM 2182-19e2
- The Virtual Family
- The MIDA Head Model
- High Precision Measurements
- Thorough Uncertainty Assessment
- 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