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Medical Device Business Development, Clinical Trials and Regulatory Strategy, Cardiology, Cardiac Electrophysiology
As a board certified electrophysiologist, Expert has extensive experience implanting and evaluating pacemakers. In addition, she was responsible for regulating pacemakers while at the FDA. Several of her publications are in the area of pacemakers. She is a board certified…
Medicated Aerosol and Inhalers
Expert has been in the field of Medicated aerosol (MDI, DPI and nebulizers) since 2004. His PhD was in this field and most of his 77 published paper and 48 conferences presentations are in this field. Expert has a respiratory…
Microbiological Contamination Control
A principal with his eponymous consulting firm, Expert has amassed 30 years of experience in academia, industry, and consulting. The majority of his research and consulting work has been in the area of microbiological contamination detection and mitigation for pharmaceutical/biotechnology,…
BioStatistics, Pharmaceutical Devices, Biotechnology, and FDA and EMA Submissions
Expert holds a Ph.D in Statistics and has 25 years' applicable industry experience. He currently serves as a biostatistical expert witness in high-stakes pharmaceutical and medical device litigations. He has expertise in pre- and non-clinical, Phases I-IV in biostatistics, data…
Dental Medical Device Industry
Expert is a marketing and advertising professional with a decade of experience in the cosmetics and dental industries. She is currently a marketing consultant at Bio-Concept Dental Implants (as of 1/2016). Prior, Ms. Expert was a Product Manager for the…
Biostatistics, Statistics, Programming, and Epidemiology
This expert is a Harvard PhD graduate and currently Associate Professor of Biostatistics at a U.S. university, where her position is tenured. Her biostatistical and statistical research and teaching includes applications Immunology and Infectious Diseases; Pathology; Epidemiology; Anesthesiology, Perioperative, and…
Medical Device Pathology
His areas of expertise include the following: • Inflammation and vascular cell biology/pathology • Medical device, drug delivery, and biomaterials histopathology • All phases of preclinical research • Regulatory, R&D, sales and marketing, and clinical issues He was a founding…
Medical Technology, Information Technology, Electrical Engineering, Biomedical Engineering, Clinical Informatics, Bioinformatics, Intellectual Property
Expert has taught and conducted research at the university level for 15 years in subjects including Computer Science, Emergency Medicine, Computational Medicine, Bioinformatics, medical technology,image processing, medical devices, and Biomedical Signal Analysis. His research interests include Big Data Analytics, Biomedical…
Good Clinical Practice (GCP), clinical trials, regulatory authority inspections, audits, QM
Expert is a former GCP inspector with the German Federal Institute for Drugs and Medical Devices [BfArM]. She has led and conducted GCP inspections on behalf of EMA and national authorities all over the world. Expert has experience in assessing…
Medical Device Product Management, Product Launch, Marketing, Sales, and Sales Operations
Expert has over 30 years commercial experience in medical and diagnostic device product management and development, marketing, sales, operations, distribution and finance as an individual Contributor, Director, Vice President and CEO. Expert provides strategic advice to start-up medical device companies,…