Medical Device Testing, Analysis and Writing
At RDMP®, we are experts in medical device testing. An example of testing, we are experienced in performing all kinds of imaging studies using modalities like x-ray, fluoroscopy, CT, CT-PET, PET, MRI and ultrasound. We also provide testing under the duress of radiation using x-rays, electrons, and even protons using imaging machines, particle accelerators, cyclotrons or radioactive material. We have tested everything from active devices such as neurostimulators, pacemakers (ICP), cardioverter defibrillators (ICD), glucose monitors, drug pumps, cochlear implants, heart pumps, artificial organs, etc to inactive devices such vascular access ports, bones and composite plastics. More specifically, we test device operation and performance (radiation immunity testing) when irradiated by Particle Accelerators for x-ray and electron testing and compatibility (ISO 14708-7 and EN 45502-2), even Cyclotron proton testing and compatibility, Diagnostic Radiology kV imaging with 10 micron resolution (100 lp/mm), CT testing and compatibility (ASME-E1441), MRI testing and compatibility up to 9.4 Tesla, Radiofrequency testing (RF) and compatibility, electromagnetic interference (EMI / EMI), Ultrasound testing (ultrasonic energy) and compatibility, Hyperbaric Pressure Chamber testing and compatibility to 3 atm, and PET testing in Nuclear Medicine for contrast studies with F-18 labeled FDG and NaF, et al. We have capabilities including finite element analysis, computational fluid dynamics, radiopacity testing, durability and fatigue testing, SEM investigation, energy dispersive x-ray spectrometry, radial force testing, electrochemical corrosion testing, immersion corrosion testing, tensile and compression testing and particulate testing. We can provide scientific writing to assist with desired bench studies, grant funding requests and clinical reports.
Testing is based primarily on standards developed by the International Organization for Standardization (ISO), American Society for Testing and Materials (ASTM), the American Society of Mechanical Engineers (ASME), European Union (EU), etc. Ref: ASME-E1441, ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213, ISO 13485, ISO 14708-1, ISO 14708-7, ISO 14117, ISO 10974, EN45502-2, IEC 60601-1-2, etc. All references for radiation dose are NIST traceable with reference paperwork provided in the report. Other testing methods or report writing can be discussed and developed per your needs, including production of Customer Evaluation Reports (CER) for TUV SUD certifications. In general, if we do not do it, when can freely refer you to our professional field colleagues who do!
To learn more about the company or to discuss new cases or projects, please contact us via the web form or give us a call at 812-557-0234.