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This web page bannickconsulting.com states the following, "Hands on preparation of PMA, 510k and IDE submissions." We viewed that the webpage stated " Clinical Evidence Reports and manuscript development." It also said " Monitoring and clinical protocol development. Regulatory strategy development and submissions. For over 25 years, Ms. Bannick has worked with device companies to bring Class II and III products to market in the US and internationally. She has a BA in biostatistics, MA in Health and Human Services Admi." The header had consulting as the highest ranking search term. It is followed by CRO, regulatory, and clinical studies which isn't as ranked as highly as consulting. The next words they used was biostatistician. clinical was included but will not be seen by web engines.