Who Is evo820?
FDA regulatory experts launch international consulting firm to help medical device manufacturers stay compliant.
Led by a respected and highly knowledgeable industry professional, evo820 takes the headache and confusion out of the FDA’s 21 CFR 820 guidance and 510(k) Submissions.
Tim has a diverse experience with the medical device manufacturing, materials, management, and regulatory affairs spanning 45 years. Tim has engaged in the development of 9 medical device systems through design, production, and their regulatory processes. He has experiences with and involved in 9 FDA audits with clients and brings his regulatory experiences from Attachments International, Glidewell Dental Laboratories and most recently Integrated Dental Systems (MegaGen).
Na Zhang, was born in Shenyang, Liaoning, China. Na achieved her B.S degree of Chemistry at University of Technology and Science of China, one of the top colleges in China. After graduating she came to US and joined the school of University of North Carolina at Chapel Hill under a full scholarship. There she achieved her doctorate degree in chemistry. She started her career as a research scientist at Den Mat holdings, focusing her research on new dental material development and 510(k) clearance. She pursued her career further in dietary and pharmaceutical industry as a quality control lab supervisor and later validation manger. She has more than 8 years’ experience of working in FDA regulated industry, focused in quality manage system.
Van has 3 years’ experience in the Regulatory Affairs and Quality Assurance field along with 10 years’ experience in the dental industry. She specializes in FDA Quality Systems, client training, customer care, and digital technology, Van works closely with dental laboratories and manufacturers on FDA Matters.