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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,…
General Surgery, Surgical Oncology, Hernia Surgery
Expert has 16+ years of general surgical experience with the types of cases outlined. He has special interest in surgical oncology and hernia surgery.
Bariatric General and Advanced Laparoscopic Surgery General Surgery
Expert is an advanced laparoscopic surgeon where his main focus of interest is in bariatric surgery for weight loss. He has been in practice since 1999 and have performed over 45000 procedures since leaving residency. He has also performed over…
General Surgery
These are areas that Expert has been trained in and perform routinely.
Product Development, Product Safety, Regulatory Compliance, Claims Support, Litigation Support
This expert has training and experience in the following areas: Safety of foods, cosmetics and their ingredients; and medical devices, pharmaceutical actives and excipients. Regulatory affairs related to foods, cosmetics, and medical devices. Product development of foods and cosmetics. Management…
Gastroenterology
Expert is board certified in internal medicine with a subspecialty in gastroenterology. After receiving his MD from Columbia University, he completed his internship and resident training in medicine at the Veterans Administration Hospital in New York in 1980 where he…
Gastroenterology, Medical Use of Voice Recognition
A leading expert on the evaluation of medical lexicons, Expert is the American representative to the international group developing the minimal standard terminology to digestive endoscopy and has a major grant to test it in the U.S. The National Library…