The Company has established a Board of Clinical Advisors, which is comprised of highly qualified physicians and healthcare industry professionals. The Board of Clinical Advisors will advise the management team in making decisions and taking action related to our clinical study efforts, product design and sales efforts. However, the Board of Clinical Advisors will not be responsible for management decisions and has no legal or fiduciary responsibility to the Company. Currently there are three members on the Board of Clinical Advisors:
Carol Krieger is an experienced Regulatory/Clinical professional with over 30 years of medical device experience in the clinical and regulatory areas. She has led and trained clinical and regulatory staff while holding strategic management positions in both large and small companies.
Her experience includes successfully developing and/or managing over 100 regulatory submissions to the FDA, including interacting with FDA product reviewers in two FDA divisions to facilitate approval of 510(k) and PMA submissions involving varied Class II and III products. Building clinical research/regulatory departments including the hiring, training and professional development of staff. She has substantial experience
She has designed and implemented multiple clinical protocols for the investigation of diagnostic medical devices for the purposes of FDA approval. Her experience includes reviewing product labeling, advertising and quality assurance documentation for compliance with FDA regulations.
Carol most recently served as the Director of Clinical Quality Assurance and Compliance at Becton Dickenson and Company. He previous experience also includes Boston Scientific Corp and Roche Diagnostic Systems, Inc..
Carol holds a Master of Science in Jurisprudence Degree from Seton Hall University School of Law, a Master of Business Administration Degree from Montclair State University, as well as a Bachelor of Science Degree in Medical Technology from Rutgers University.