Independent Consultant
An accomplished scientific consultant with a Ph.D. in Molecular & Cellular Biology and an M.B.A. with a concentration in Strategic Management. He boasts over 35 years of experience in biomedicine and big data analysis, with expertise in performing safety and toxicological assessments, reviewing pre-clinical and clinical studies, and evaluating post-market surveillance data for FDA-regulated produc...
Experience: 17+ years
Submissions: 50 510(k), 10 De Novo, 5 PMA
Diego Rua provides regulatory consulting services to clients in:
Dr. Rua holds a Ph.D. in Biological Sciences with a concentration in Molecular & Cellular Biology from Wayne State University and an M.B.A. with a concentration in Strategic Management from Davenport University. This strong academic foundation in biological sciences and business strategy provides a unique advantage in understanding the complex interplay between scientific innovation and regulatory compliance within the medtech industry.
Dr. Rua has authored 28 peer-reviewed publications and holds 1 patent, demonstrating significant contributions to scientific knowledge. He has been an invited guest speaker at international conferences and received the 2019 CDER Recognition Honor Award as part of the Sunscreen Broad Spectrum Analysis Group and the 2018 FDA Regulatory Science Excellence award for his innovative research.
With over 25 years of experience, Dr. Rua has a distinguished career spanning critical roles in both government and industry. He has served as a Research Biologist/Reviewer at the FDA's CDRH and CDER, evaluating the safety and biocompatibility of medical devices and FDA-regulated products. His experience also includes significant contributions to the personal care and consumer goods industries, managing clinical studies, and developing safety assessments. This diverse background offers a comprehensive understanding of regulatory landscapes from multiple perspectives.
An accomplished scientific consultant with a Ph.D. in Molecular & Cellular Biology and an M.B.A. with a concentration in Strategic Management. He boasts over 35 years of experience in biomedicine and big data analysis, with expertise in performing safety and toxicological assessments, reviewing pre-...
Dr. Diego Rua presents an exceptionally rare and valuable combination of a former FDA CDRH Reviewer, a Ph.D. scientist, and a big data/AI specialist. With 17 years of consulting experience built on a 35-year foundation in biomedicine, his expertise is both deep and broad. His direct experience inside the FDA, validated by a CDRH Reviewer Certification, provides medtech companies with an invaluable 'insider's perspective' to de-risk submissions. This is complemented by a robust track record of over 50 510(k)s, 10 De Novos, and 5 PMAs, and a unique proficiency in AI/ML and data analytics, making him a critical asset for companies developing next-generation medical devices.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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