Advancing medical treatments require steadfast attention to shifting regulation and market dynamics for medical technology companies. Gradient has significant expertise in biological safety, toxicology, chemistry, and regulatory compliance, and we routinely develop innovative, health-based risk assessments to support product development decisions and regulatory filings for the medical device and biotechnology industry.
We can develop strategic biological safety evaluation plans to meet ISO 10993 and ISO 18562 requirements. We support chemical characterization of medical devices, including nanoparticles, and evaluate patient safety in a toxicological risk assessment.