Daniel is a regulatory affairs professional with over 30 years of experience with in vitro diagnostics (IVD) and medical devices. Daniel received a Bachelor of Science in Biological Science with a minor in Microbiology from Colorado State University. He spent the first 15 years of his career as a research scientist developing diagnostics for human and veterinary applications. In 2008, Daniel became the Director of Regulatory Affairs and Quality at Corgenix Inc., an IVD company with its own product line and also offering full a full suite of contract development services. After 14 years at Corgenix leading the Regulatory, Quality and Clinical divisions, Daniel established and grew regulatory consulting services at ERI Group, a full-service development and engineering firm that specialised in medical devices. In this role, Daniel worked with both medical devices and IVD products. After 3 years at ERI Group, Daniel founded an independent regulatory affairs consulting firm prior to joining DCN Dx.

Daniel’s passion as a regulatory expert is helping IVD and medical devices companies of all sizes efficiently navigate the complex and ever changing global regulatory frameworks to bring their medical technology to market successfully and efficiently.  Daniel specialises in supporting the path to market for innovative technologies and unique indications to prepare the least burdensome, compliant approach to take. At DCN, Daniel works seamlessly and collaboratively with R&D scientists, manufacturing teams, clinical teams, sales, and business administrators to set and achieve regulatory program goals. Daniel has many years of experience working directly with the U.S. FDA and is experienced with how to communicate with the agency effectively to achieve favourable outcomes.

DCN Dx is a Contract Development and Manufacturing Organisation (CDMO) and Clinical Research Organisation (CRO) with deep expertise in diagnostic product development, clinical study design, regulatory strategy, and submission. Our Regulatory Services team, brings over 30 years of experience in in vitro diagnostics (IVDs) and medical device regulatory affairs.