Home Office
California - Irvine
15235 Alton Parkway
Suite 120
Irvine,
CA
92618
- Phone: (949) 336-9001
- Fax: (949) 336-9020
Dr. Felicia L. Svedlund is a Senior Consultant at ESi. Dr. Svedlund has over 13 years of broad experience in the realms of materials science and engineering, biomaterials, and biomedical engineering and possesses a comprehensive understanding of the complexities involved in the development and application of medical devices. Dr. Svedlund’s expertise encompasses the design, testing, and manufacture of medical devices and the materials from which they are constructed; failure analysis and non-destructive examination of medical devices and the multi-factorial assessment of their performance; and evaluation of medical device design, testing, manufacturing, risk management, postmarket surveillance, and regulatory documentation to ensure compliance with Quality System Regulation (QSR), U.S. Food and Drug Administration’s (FDA) requirements and guidance documents, and consensus standards, such as American Society for Testing and Materials (ASTM) and International Organization of Standardization (ISO).
Dr. Svedlund's unique approach to failure analysis and evaluation of explanted medical devices sets her apart in the industry. She incorporates a multi-factorial approach, considering device factors, as well as patient and surgical factors. Her expertise extends to various categories of medical devices and surgical instruments, including orthopaedic devices like total knee arthroplasty, total hip arthroplasty, fracture fixation devices, and spinal implant devices, as well as interventional cardiology devices, surgical coagulation and cutting devices, women’s health and feminine hygiene products, inferior vena cava (IVC) filters, ventilators, and wearable cardiac defibrillators.
ESi's expertise spans dozens of industries and specializations organized across several practice groups, each staffed by dozens of in-house experts with the technical knowledge, hands-on expertise, and courtroom experience required to execute projects for and with our clients from start to finish.
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