Medical Device FDA Regulation & Quality Expert

Specialties & Experience of this Expert Witness

Additional Information

Dr. Ediuska Laurens is a highly credentialed biomedical engineer and expert in FDA regulation, compliance, and product liability for medical devices and biologics. She provides expert witness services to both plaintiff and defense counsel in litigation involving medical device and biologics FDA approval and clearance, labeling and warnings, quality systems, adverse event reporting, clinical trials, and post-market surveillance. Dr. Laurens brings over 20 years of combined industry, research, and regulatory experience. She has led regulatory and quality efforts across the entire medical device lifecycle, from concept through commercialization, supporting product development, regulatory submissions, and quality compliance for a wide range of technologies, including cranial and orthopedic implants, spinal and neural devices, tissue engineered-biologics and combination products, hydrogel biomaterials, as well as pediatric and women’s health innovations, among others. Attorneys rely on her to interpret complex FDA requirements and clearly articulate whether medical technologies complied with applicable regulatory and quality standards at each stage of their development and market presence. As founder of Genius Shield, she provides regulatory and quality support to medical technology companies and investors, including due diligence assessments, and compliance strategies across U.S. and EU markets. She has helped numerous clients achieve FDA clearance/approval, mitigate product risks, and strengthen quality management systems in line with ISO 13485 and 21 CFR Part 820. Earlier in her career, Dr. Laurens held leadership roles at a Fortune 500 medical device manufacturer, where she led cross-functional teams in the development and successful commercialization of Class II and III implantable products. Her name appears on multiple patents, and her contributions have won patent innovation award and driven multimillion-dollar product launches. She has published in peer-reviewed journals, lectured at global conferences, and frequently presents on the intersection of FDA regulation, clinical safety, and medical innovation. Her ability to bridge engineering, regulatory, and clinical dimensions makes her a valuable resource in product liability disputes involving allegations of design defects, manufacturing lapses, and regulatory noncompliance. Bilingual in English and Spanish, Dr. Laurens is a clear, effective communicator in depositions and at trial. She has been engaged as a scientific speaker by institutions such as Johns Hopkins, Columbia University, and serves as a trusted advisor to the Women’s Health Innovation Coalition and Springboard Enterprises. Her expert witness services are frequently sought in matters involving: Medical Device Product Liability & FDA Compliance FDA Warnings, Labeling, and Instructions for Use (IFUs) Clinical Trials & Human Factors under FDA Oversight Medical Device & Biologics FDA Approval/Clearance (510(k), De Novo etc) FDA Adverse Event Reporting, Complaints & Recalls Design Controls, Risk Management & Quality System Failures Biomedical Engineering and Biomaterials Available for: Case reviews, expert reports, deposition, and testimony nationwide.