Medical Device Expertise

Design and Development of Orthopaedic Medical Devices

Mari is experienced in the product design and development of orthopaedic medical devices. She has designed and developed implants and instruments used for both human joint reconstruction and skeletal trauma reconstruction and repair. Mari draws on her strong knowledge of FDA and ISO EN13485 compliant design control processes, failure modes and effects analysis, clinically relevant tissue loading, and design safety assurance, including device performance requirements and warnings. She has a strong knowledge of the production and quality assurance processes used in the manufacture, cleaning, and sterilization of medical devices and the effects of such processes on product performance.

Product Development

Mari has a diverse design background that spans the complete product development cycle. She has been responsible for the safe design of medical devices from initial concept through hazard analysis, prototyping, testing, manufacturing, QA, and product release. She has engineered a wide variety of orthopaedic medical devices, such as trauma plates, screws, pins, wire, intramedullary nails, external fixation frames, spinal fusion devices, soft tissue anchors, tendon repair, and total joints (hip, knee, wrist, finger, toe, elbow, ankle, shoulder implants, and surgical instrumentation), and is thoroughly knowledgeable in safe design and safe manufacturing processes. She performed her work in compliance with ISO EN13485 and FDA guidelines as required in 21 CFR part 820.

Forensic Consult

Cases generally begin with a preliminary review of a patient's medical records and images to determine case facts and issues to potentially address. It is important that Mari conducts a review of the injured person's health history, daily physical activities and event medical records, including operative reports and imaging studies because as an expert, she needs a complete picture of the person to provide a complete analysis. This typically takes one to three hours to determine the health status of the person. Contact Mari for specific pricing.