Fda Qms & Design Controls Expert Witness Listings

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Ediuska V. Laurens, MS, Dr.Eng.

Jersey City, New Jersey
Medical Devices Expert Witness, Biomedical Engineering Expert Witness - Craniomaxillofacial/ Cranioplastic Implants, Medical Devices Regulations & Standards: 21 CFR 820, ISO 13485, FDA QMS & Design Controls, FDA 510k & CE Mark clearance, Risk Management, Pediatric Mandibular Distraction, Distraction Technology, Biomaterials, Bioresorbles, Hydrogels
As a biomaterials and medical device product development expert with 8 years plus of experience, I have developed pediatric Craniomaxillofacial implants from concept to global commercialization in Fortune 500 medical firm. I have successfully developed, FDA-CE Mark cleared, and launched Distraction, Bioresorbable, and Bone Cement technologies. I am the author of several published scientific articles in hyaluronan and collagen hydrogel biomaterials for cartilage and spine repair, and conference speaker in the same fields. I am the inventor of 2 patents in: pediatric mandibular distraction and bioresorbable polymer plating, respectively. I have led the entire product development process from concept, design, development, verification and validation testing, production and commercialization. My strong research background provides me with extensive experience and enhanced ability to analyze scientific data and identify strengths and weaknesses in both scientific methods and data. I am a...
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