Regulatory and toxicological consulting spanning the full biological evaluation process — from initial strategy to gap-free compliance.
Bringing a medical device to market safely means demonstrating biocompatibility to a standard regulators trust. We support that process end-to-end — from the strategic plan that scopes your testing, through chemical characterization and toxicological risk assessment, to the final report regulators review.
Whichever stage you're at, our ERT and DABT-certified toxicologists align every assessment to ISO 10993, ISO 14971, FDA guidance, and EU MDR.
The foundational ISO 10993-1 document defining your device's body-contact category, duration, and required biological endpoints.
Learn moreEvaluating health risks from chemicals that may leach from a device's materials against toxicological thresholds.
Learn moreIdentifying and quantifying chemicals released from a device through extractables and leachables studies.
Learn moreThe comprehensive report compiling all data and risk assessments into the safety conclusion regulators review.
Learn moreComparing existing documentation and testing against current requirements, with a prioritized action plan.
Learn moreBiocompatibility evaluation of breathing gas pathways in ventilators and anesthesia machines — particulate emissions, VOCs, and condensate leachables.
Learn moreTalk to our regulatory and scientific experts today.
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