Dr. David Eaker is a board-certified toxicologist with three decades of experience guiding devices, drugs, and combination products from early concept to global regulatory approval. He has led GLP laboratories, built cross-functional safety programs, and authored more than 300 health-risk assessments supporting a multibillion-dollar product portfolio—establishing himself as a recognized thought leader in biocompatibility, extractables-and-leachables science, and toxicologic risk assessment.

At Endpoint Preclinical, David pairs that depth with a broad, end-to-end perspective. Acting as a program architect, he designs cohesive preclinical roadmaps, aligns toxicology and analytical evidence with regulatory and clinical goals, and draws on the Endpoint network to assemble best-fit experts for each study phase. For clients needing focused guidance, he also provides stand-alone toxicology consulting—delivering authoritative opinions, gap analyses, and risk narratives that meet the highest global standards

• Preclinical Program Design & Coordination – Builds phased, hypothesis-driven study plans that integrate safety, efficacy, and compliance requirements.
• Toxicology, E/L & Risk Assessment – Leads biocompatibility strategies, comprehensive extractables-and-leachables evaluations, FMEA, and health-hazard analyses.
• Regulatory Strategy & Submission Support – Extensive track record with IDE, PMA, 510(k), IND, NDA, and global equivalents; seasoned agency liaison.
• Laboratory & Quality Systems – Deep knowledge of GLP, GMP, ISO 13485/17025; designs and optimizes in-vitro and in-vivo model laboratories and analytical facilities.
• Data Integration & Reporting – Synthesizes imaging, clinical chemistry, pathology, and PK data into decision-ready reports and risk-benefit narratives.
• Thought Leadership & Training – Active contributor to FDA and ISO working groups; provides workshops on toxicology strategy and lifecycle evidence generation.

David believes innovative med-tech must address unmet medical needs without compromise to patient safety or research ethics. Early, open collaboration—coupled with rigorous planning and transparent dialogue with regulators, standards bodies, and clinical experts—ensures programs advance efficiently, credibly, and humanely.

Experimental Design
Toxicology Consulting
Data Collection
Data Analysis
Reporting
Interpretation
Regulatory & Compliance
Risk Assessment
Product Development
Training