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Medical Device Regulatory Affairs: CE (Canada) and FDA
Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…
Mold Allergy, Water Damage Exposure, Asthma, Allergic Rhinitis, Hypersensitivity Pneumonitis.
Expert is a board-certified allergist-immunologist and has been retained as a medical expert witness in nearly 300 cases involving adverse health effects from water damage and mold exposure. He has also testified in at least 6 trials related to these…
Dermatology and Cosmetic Surgery, Techniques, Applications and Technology
Expert graduated from Tulane University School of Medicine in 1990 and completed his residency in Dermatology and Cutaneous Surgery at the University Of Miami School Of Medicine in 1994. Expert is a Diplomate of the American Board of Dermatology and…
Dermatology, Cosmetic Dermatology, Laser, Botox, Fillers, Medical Administration, EMR
Expert has practiced dermatology for over 20 years, treating both adults and pediatric patients in a large multispecialty practice in the Boston area. Expert is board certified in dermatology and internal medicine. Expert has been performing medical and cosmetic laser…
Medical Device Regulatory Submissions
She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic…