Department of consulting

MR:comp offers comprehensive consulting services to manufacturers of items and devices that are used in the magnetic resonance environment. With our sister Reseach Institute MRI-STaR unsing their early-stage R&D design support, you can save resources for R&D as well as for MR testing and prevent failures during product approval. This MRI-STaR service optimizes the MRI safety performance of devices also from marketing point of view.

Further, MR:comp offers the following services:

• MRI safety testing consulting services for in-house production of medical devices
• Worst-case analysis of product matrices, shrinking the number of cases for numerical simulation and experimental testing
• Regulatory Submission Consulting (Q-Sub, 510k, PMA, etc.) MR safety related with our RA expert Dr. Wolfgang Kainz, HPC for MRI Safety (formerly 20 years US FDA consult reviewer for MRI safety)
• Bioheat transfer simulations according to different models (Shrivastava Algorythm, Pennes Equation, Tissue Simulated Models)
• In-Vitro to In-Vivo Transfer (IVIV, 'Tier 2.5') of RF heating testing results from ASTM F2182 phantom testing into the the human model realistic and clinical anatomical tissue (ASTM F2182 Chapter 9. 'Guidelines on Determination of Labeling Based on Implant Testing')
• MR labeling / MR marking of devices according to the FDA guidance for Industry and FDA Staff (2021): Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment
• MR labeling / MR marking of devices according to CE requirements
• Consulting services to MR users
• Expert opinions on device-specific situations in magnetic and electromagnetic fields in MRI
• Development of device specific test plans
• R&D accompanying test series and numerical simulation for prototype optimization in MRI fields
• Risk management for devices and MR sites
• Workflow optimization for MR sites
• Translation services

Please note: Although "MR Safety" is the correct technical term, the term "MRI safety" is also used in this text to reflect the colloquial use.

We offer MR safety and compatibility assessment and testing support for all non-active (passive) and active medical devices such as implants, instruments and accessories for use outside and inside the MR envrionment (terms see ASTM F2503, IEC 62570, IEC 60601-2-33) amongst:

Instruments:

• Catheters, Guidewires, Biopsy needles, Ablation catheters, Drainages

Orthopedic implants:

• Hip joints, Shoulder prosthesis, Knee joints, Bone fixators, External Fixators, Plates, Screws, Bone Nails, Bone extendenders, Skull plates, Dental implants and abutments, Individual orthopeadic implants, Spine implant systems

Medication Ports, Halo vests, EEG and ECG systems, Navigation systems, Oximeters

Cardio- and Endovascular implants:

• Coronary and Peripheral stents, Grafts, Artificial heart valves, Aneurysm coils & clips, Vena cava filters, Occluders

Active medical Implants (AIMD):

• Implantable cardioverter-defibrillator, Cardiac pacemakers, Cardiac monitors, Implantable medication pumps, Neurostimulators, Sleep apnoe, Drop Foot Loss, Cochlear Implants, Bladder, Disfunction stimulators, Deep brain stimulators, Spinal cord stimulators, Heart assist systems

MR accessories:

• Wheelchairs, Tables, Beds, Stretchers, Patient trolleys, Monitors, Contrast media injectors, Medication pumps, Oxygen tanks, Infusion pumps, IV pumps, Video goggles, Audio systems, Pulse oxymeters

and many other individual devices and items