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Marlo A. Mravec
Clinical
A qualified auditor (ASQ CQA) and Clinical Research Associate (CCRA), Ms. Mravec brings valuable clinical trial experience, along with knowledge in FDA regulations, CE mark Certification & IVDD Requirements to the product design process. Recent work has focused on assisting foreign companies with FDA guidances. A skilled auditor, Ms. Mravec integrates real life experience gained from FDA audits into the cGMP auditing process. She has worked for companies such as Bayer, Baxter Healthcare and MonoGen. Her work has received national recognition from Children With Diabetes magazine. Ms. Mravec specializes in quality system and design control for PMA devices and has a passion for integrating user needs into product design.

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