Meet our Subject Matter Experts

Phillip Smiraldo, PhD, DABT

Principal Toxicologist

Biocompatibility, Biological Safety, Preclinical, Toxicology

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Rachel Gibbs, BSc, PhD

Principal Regulatory Consultant

EU IVDR/MDR, Worked for Notified Body

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Sarah B. Nelson, MS

Senior Strategy Consultant, Regulatory

EU IVDR/MDR, In Vitro Diagnostics, US FDA

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Séverine Oudin-Fantin, PhD

Manager–EMEA Medical Writing Services

EU IVDR/MDR, Medical Writing

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Shazia A. Siddiqui, MS, NRCM

Principal Microbiologist

Cardiology, Microbiology, Ophthalmology, Wound Care

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Shelley L. Green, BS

Senior Validation Scientist

Microbiology

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Silke Laugeois

Principal Biological Safety Scientist

Biocompatibility, Biological Safety, EU IVDR/MDR

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Staci L. DeMoss, BS

Principal Validation Scientist

EU IVDR/MDR, US FDA

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Sylvie Framery, PhD

Senior Principal Biological Safety Scientist

Biocompatibility, Biological Safety, US FDA

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Tawnya J. Meier, MD

Director of Safety

Data Management

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Thomas Miramond, PhD, MSc, M-Eng.

Senior Regulatory Consultant

EU IVDR/MDR, Preclinical, Worked for Notified Body

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Thomas Vanderveken, MD

Associate Medical Director

Data Management

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Tim Petermann

Principal Chemist

Chemical Characterization, US FDA

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Tracy Murphy, BS

Senior Project Manager, IVD

In Vitro Diagnostics, Medical Writing

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Travis Schaefers, RCIS

Interventionalist

Preclinical

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