Delivered via Harmoni Analyticals
Accredited laboratory testing for biological safety.
Laboratory testing is performed at our sister laboratory, Harmoni Analyticals — an OECD GLP Certified, NABL Accredited facility — and interpreted by our regulatory and toxicology team.
These accreditations are held by our sister laboratory, Harmoni Analyticals. Harmoni Regulatory Services designs the studies and integrates the results into your regulatory submissions.
Biocompatibility Evaluation
Biological Evaluation Plans (BEP) and Reports (BER) built on the ISO 10993-1 framework and scoped to your device's exposure profile.
Chemical Characterization
Material chemistry and extractables studies to characterise device constituents per ISO 10993-18.
Extractables & Leachables
E&L study design and analytical execution to support biological safety and toxicological assessment.
Toxicological Risk Assessment
Toxicological Risk Assessment aligned to ISO 10993-17 to interpret chemistry data and justify biological safety.
Get Started
Tell us about your device and target markets.
Share your device and regions of interest and our team will respond with a tailored regulatory outline within two business days.