I perform regulatory strategy for digital health companies on potential paths free of FDA regulation and regulatory/quality affairs services for FDA regulated digital health and medical device companies. I developed and run kBLASTER®, an actionable insight SaaS search of the entire contents of publicly available FDA 510(k) summaries when seeking a predicate for a 510(k) submission. kBLASTER® also offers consulting for customers needing 510(k) submissions services.
I strategically assist companies ranging from pre-revenue to mature medical device and/or digital health companies when trying to navigate the FDA regulatory landscape for their product(s). I also perform regulatory affairs and quality affairs services for FDA regulated medical device and/or digital health companies, so they can meet their FDA compliance requirements, including 510(k) submissions for FDA clearance to market product.