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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,…
Biomaterials, Intraocular Lens Implants, DNA Analysis
Expert has completed doctoral studies in developing a novel polymer for intraocular lens implants. During this study she has designed several new experimental methods to detect polymer biocompatibility and toxicity to ocular and other cell types. Expert also has extensive…
Biological Responses to Medical Device Materials and Coatings
Expert M was responsible for the development of a novel, biocompatible, bioactive, bone-like bone cement, suitable for usage in craniofacial applications. Expert M completed his PhD in Medical Materials Engineering at Kings College University of London in May of 2004,…