Angie Purvis, PhD brings a wealth of experience leading diagnostic and medical device products to market by successfully combining her broad scientific and product development skills and her regulatory expertise to create high-quality in vitro diagnostics, laboratory-based diagnostics (CAP/CLIA), and medical devices. Angie has extensive experience navigating complex regulatory pathways for medical products in the USA, EU, and developing/emerging markets.

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Angie enjoys working with companies that are challenged to understand how to implement Quality Management Systems into everyday practice, especially in the application of Design Control to the product development cycle. She enjoys bridging the gap between the practices of research scientists and engineers and the expectations of Quality and regulatory.

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She is a board-certified CLIA Laboratory Director for high-complexity testing across the USA and through the New York State Department of Health. Angie enjoys building CLIA laboratories and validating the environment and technologies. She specializes in helping CLIA laboratories performing LDTs (lab developed tests) ensure high quality validation of those tests and achieve accreditation through CLIA and/or clearance or approval through FDA.

 

Angie completed her PhD (Biochemistry) and post-doctoral training at Washington University at the Howard Hughes Medical Institute (HHMI).

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