Dr. Ediuska Laurens
Biomedical Engineer. Medical Device Product Dev., Regulatory & Quality Compliance
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Professional Summary
Dr. Ediuska Laurens, EngD; M.S. is a biomedical engineering expert specializing in medical device product development, regulatory compliance, and quality assurance. With a career encompassing leadership in medical device innovation and regulatory strategy, she brings a multidisciplinary perspective to her litigation work. Her work centers on investigating regulatory adherence, assessing product safety, and evaluating compliance with FDA standards.
Dr. Laurens has been retained in numerous expert witness and consulting engagements across the USA and EU, involving medical device product liability and FDA regulatory cases. Her Doctor of Engineering in Biomedical Engineering - Biomaterials, along with her Master of Science in Mechanical Engineering - Biomaterials, reinforce her ability to deliver objective, defensible analyses. She is regularly engaged by both plaintiff and defense counsel to provide clear, independent determinations of regulatory compliance in disputes involving medical devices and FDA regulations.
Work Experience
Dr. Ediuska Laurens is the Founder & CEO at Genius Shield LLC since November 2018. She previously served as a Senior R&D Project Manager at Stryker Craniomaxillofacial from January 2011 to October 2018 and was a Research Engineer - Post Doctoral Fellow at Cleveland Clinic Foundation Lerner Research Institute from September 2005 to December 2010. Her career began as a Research Assistant at State University of New York (SUNY) at Buffalo from May 2002 to August 2005.
Expert Intelligence
Best Descriptor
Dr. Ediuska Laurens specializes in guiding medical devices through regulatory compliance and quality assurance processes.
Best Use Cases
- 1FDA compliance consulting for medical device companies
- 2Quality management system implementation for medical devices
- 3Regulatory strategy development for new medical products
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View full reportEducation
Doctor of Engineering in Biomedical Engineering - Biomaterials
Cleveland Clinic Foundation - Cleveland State · 2009
Master of Science in Mechanical Engineering - Biomaterials
State University of New York (SUNY) at Buffalo · 2005
Bachelor of Science in Aerospace Engineering
State University of New York (SUNY) at Buffalo · 2003