Laura Beringer, Ph.D., President
Before establishing Integritas, I held senior roles within a major global medical device manufacturer and a small CRO, where I led large-scale biocompatibility testing programs and toxicological risk assessments and managed remediation for high-profile issues. Today, I use that "front-line" experience to get regulatory submissions through notified bodies using a combination of rigorous scientific testing and technical justification where appropriate, with a foremost commitment to patient safety. I have expertise in developing custom assays to answer specific questions while using the standard ISO 10993 framework to guide toxicological and overall biological risk evaluation.
James Horne, Ph.D. Senior Partner
Regulatory toxicologist and biocompatibility specialist with extensive experience in designing comprehensive experimental paradigms that capture real-world clinical use cases and exposure pathways. I bring a holistic and meticulous scientific approach to biological evaluations, focusing on the critical intersection between device characteristics, patient exposure routes, and toxicological endpoints to develop robust risk assessment strategies. My expertise spans ISO 10993 and ISO 18562 frameworks, with particular strength in translating complex chemical characterization and biological data into clinically relevant safety conclusions. I specialize in crafting fit-for-purpose study designs that address device-specific toxicological questions while ensuring regulatory compliance across FDA and international submission pathways. Through rigorous experimental design and comprehensive risk characterization, I help clients navigate complex biocompatibility challenges, providing scientifically defensible conclusions that prioritize patient safety while supporting successful regulatory outcomes.
