Dave is a regulatory expert in medical devices who directs the regulatory affairs and quality system activities at LEVL. He received his MS in Biomedical Regulatory Affairs from the University of Washington where he is now a lecturer and directs the clinical trial program for the School of Pharmacy’s BRAMS program. Dave has worked with biotechnology companies for nearly 20 years and is the principal consultant at his own practice where he focuses on regulatory issues associated with research, development and FDA requirements for biologics and medical devices. Dave provides advice to early stage and established biomedical product companies on regulatory issues across the product lifecycle, from bench top to clinical research, FDA pre-market requirements, labeling, and promotion and advertising. He has presented at several national and regional conferences on clinical research and regulatory topics and is the author of a number of articles in his field.