Science. Safety. Compliance.
Expert toxicology solutions for safe, compliant, successful products — smarter toxicology for better regulatory decisions, delivering comprehensive biological safety evaluation for medical devices worldwide.
expertise
Toxicology specialists for the medical device industry
BIOTOX by MedReg is a dedicated toxicology and biological safety practice. We help medical device manufacturers prove that their products are biologically safe — and get that proof accepted by regulators the first time.
Our internationally certified toxicologists prepare Biological Evaluation Plans and Reports, toxicological risk assessments and in-silico safety assessments for devices of every risk class, from skin-contact accessories to long-term implants.
- DABT, ERT & UKRT certified
- ISO 10993-1:2025 aligned
- Class I, II & III devices
- FDA, EU MDR & CDSCO
- Non-animal approaches
- Response within 2 hours
Our mission
To make biological safety evaluation faster, more scientific and less dependent on animal testing — so that safe medical devices reach patients sooner, in every market.
Our vision
To be the toxicology partner manufacturers trust for regulator-ready biological safety documentation, wherever in the world they choose to sell.
Our values
Science first
Every conclusion rests on data, literature and sound toxicological reasoning — never on templates.
Patient safety
We evaluate devices as if our own families were the patients, because ultimately someone’s are.
Fewer tests, not less rigour
Risk-based strategies and justified waivers reduce animal testing and cost without cutting corners.
Global by design
One cohesive documentation strategy for FDA, EU MDR, CDSCO, Gulf and ASEAN markets.
Ready to make your device submission-ready?
Talk to a DABT · ERT · UKRT certified toxicologist about your biological evaluation. Direct expert response within 2 hours.