- Biological Assessment -
Avoid unnecessary animal testing.
Ensure your product's biocompatibility is safe and cost-effective.
Don't jeopardize your product's revenue with slow and expensive biological assays.
At DMH GROUP, your Biological Assessment (ISO 10993) is designed exclusively by experts with over 15 years of real-world market experience, using scientific intelligence to guarantee approval from ANVISA (Brazilian Health Regulatory Agency) .
The Cost of Uncertainty vs. Real Return with DMH Group
Every month your device is locked up due to flaws in the biocompatibility strategy is costing your company dearly. Submitting your documentation to theorists generates endless demands.
Brutal Capital Economy
We replace slow and expensive in vivo (animal) tests with strategic tests or robust technical justifications. Drastically reduce laboratory costs.
Defense by Toxicological Evaluation
We are experts in Chemical Characterization (ISO 10993-18) and Toxicological Risk (ISO 10993-17) standards. We defend your company's dossier with irrefutable data.
Launch Predictability
Without endless ANVISA requirements. Our regulatory maturity allows us to predict launch dates with precision, guaranteeing a return on product development.
Regulatory Security from the perspective of ISO 10993 and RDC 751/2022
+15 Years
Years of Active Experience
Implementing and defending real biocompatibility strategies in the LATAM market.
Biological assessment is not simply about ordering standardized test panels. Our differentiator is creating a logical risk mitigation strategy that health agencies expect and approve.
Biological Assessment Plan (BEP): Initial strategy focused on material characterization and justifications for not performing redundant tests.
Biological Assessment Report (BER): Robust dossier integrating chemical, biological, and advanced clinical toxicology data.
International Passport: Dossier compliant with FDA and European MDR, simplifying your global business expansion.
Zero
Useless Theory
Direct, to-the-point strategies, with an absolute focus on reducing laboratory costs.
"Zero Defect" Standard Methodology
Maximum optimization of regulatory deadlines while ensuring scientific integrity.
We don't sell isolated reports. We deliver market compliance for your product.
DMH GROUP's regulatory consulting division combines the highest international scientific rigor with the experience of those who master ANVISA's requirements and market expansion strategies for healthcare throughout Latin America.
Speak to those who have mastered practical results.
Fill out the form below to schedule an initial strategic biocompatibility diagnosis for your device.