Medical Devices & Diagnostics
I work with invention, manufacturing, regulatory affairs, and clinical application of artificial hearts.
Ehrreich Consulting offers insider expertise in medical devices, diagnostics, and the FDA approval process. Our extended team consists of experts in drug chemistry, pharmacokinetics, clinical trial design, statistics and biostatistics. Whether assisting with a simple device that follows general controls or a novel medical device requiring approval, we provide our regulatory consulting services to a variety of biomedical engineering companies, from family-owned start-ups to major multinational firms.
We can compare seemingly “new” medical devices to existing, previously-approved predicate devices to look for Substantial Equivalence. If the devices appear substantially equivalent, we prepare and submit a 510(k) application to the FDA for clearance. If, however, we find a significant difference in the design, manufacture, materials, chemical composition, or use of the device, we assemble a Premarket Approval (PMA) application. The key to obtaining FDA approval of our PMAs is to present the design, manufacturing, preclinical and clinical studies in a way that demonstrates their safety and efficacy.
Ehrreich Consulting has worked on a vast array of medical devices and diagnostics, led by our Project Manager, Mr. Benjamin Rawlings. From acupuncture to self-hypnosis tapes, iontophoretic devices for hair growth to depilatory lasers for hair removal, and periodontal diagnostics to defibrillators, Ehrreich Consulting has seen its share of medical devices. We have been instrumental in securing the FDA approval of devices such as chiropractic tables, and Australian clearance of retractable safety syringes.
We have experience with each of the three classes of medical device, from basic devices that come in contact with the human body (Class I), to complex diagnostic tests (Class II) to implanted devices necessary to sustain life (Class III). We have evaluated preclinical and clinical protocols, raw data, and finalized reports on these devices. Our formulation of regulatory strategies, including FDA interaction and coordination, has been successful. Ehrreich Consulting prevents potential regulatory roadblocks in medical device development and solves regulatory problems in all stages from invention to bench-testing to approval.