Meet our Subject Matter Experts

Monica R. Montañez, MS, RAC, CQA

Principal Strategy Consultant, Regulatory

Cardiology, Neurology, Ophthalmology, Software, US FDA, Vascular, Wound Care

Mukarram Mohiuddin, MPH

Mukarram Mohiuddin

Clinical Database Developer, IVD

Cardiology, Data Management, In Vitro Diagnostics, Ophthalmology, Orthopedics, Wound Care

Niki Porter, BS, CVT, LAT, SRS

Biocompatibility, Neurology, Orthopedics, Preclinical, Wound Care

Peter Shores

Principal Biostatistician

Biostatistics, Cardiology, Medical Writing, Orthopedics, Vascular, Wound Care

Petra Meijer

Senior Clinical Data Manager

Cardiology, Data Management, Neurology, Orthopedics, Trial Management

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Phillip Smiraldo, PhD, DABT

Principal Toxicologist

Biocompatibility, Biological Safety, Cardiology, Neurology, Ophthalmology, Orthopedics, Preclinical, Toxicology, Vascular, Wound Care

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Rachel Gibbs, BSc, PhD

Principal Regulatory Consultant

EU IVDR/MDR, Worked for Notified Body, Wound Care

Sarah B. Nelson, MS

Senior Strategy Consultant, Regulatory

In Vitro Diagnostics, Orthopedics, US FDA, Worked for US FDA, Wound Care

Séverine Oudin-Fantin, PhD

Manager–EMEA Medical Writing Services

EU IVDR/MDR, Medical Writing, Orthopedics, Wound Care

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Shazia A. Siddiqui, MS, NRCM

Principal Microbiologist

Microbiology, Wound Care

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Shelley L. Green, BS

Senior Validation Scientist

Cardiology, Microbiology, Neurology, Ophthalmology, Orthopedics, US FDA, Vascular, Wound Care

Principal Biological Safety Scientist

Silke Laugeois

Principal Biological Safety Scientist

Biocompatibility, Biological Safety, EU IVDR/MDR

Staci L. DeMoss, BS

Principal Validation Scientist

Cardiology, Microbiology, Neurology, Ophthalmology, Orthopedics, Vascular, Wound Care

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Sylvie Framery, PhD

Senior Principal Biological Safety Scientist

Biocompatibility, Biological Safety, Cardiology, Neurology, Ophthalmology, Orthopedics, Toxicology, US FDA, Vascular, Wound Care

Tawnya J. Meier, MD

Director of Safety

Cardiology, Neurology, Ophthalmology, Orthopedics, Safety Management and Reporting, Vascular, Wound Care

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