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***Now offering HR Mass Spectrometry services for Medical Device chemical characterization study per ISO 10993:18:2018 ***
Who we serve
Who we serve
2SD Toxicology Services LLC specializes in the safety assessment of medical devices and diagnostic products. Our team is comprised of highly skilled professionals, including laboratory scientists, analytical chemists and board-certified toxicologists, who share a common goal of prioritizing patient safety in their work.
2SD Toxicology Services LLC specializes in the safety assessment of medical devices and diagnostic products. Our team is comprised of highly skilled professionals, including laboratory scientists, analytical chemists and board-certified toxicologists, who share a common goal of prioritizing patient safety in their work.
Our approach is grounded in data-driven safety assessments, and as our name suggests, our reports are based on rigorous statistical analysis. We adhere to the most up-to-date guidance from regulatory bodies such as the ISO, FDA, and EU-MDR for medical devices and and in-vitro diagnostic products.
Our approach is grounded in data-driven safety assessments, and as our name suggests, our reports are based on rigorous statistical analysis. We adhere to the most up-to-date guidance from regulatory bodies such as the ISO, FDA, and EU-MDR for medical devices and and in-vitro diagnostic products.
With years of experience in biomedical research, we offer our clients confidence and guidance to ensure their products meet the highest safety standards.
With years of experience in biomedical research, we offer our clients confidence and guidance to ensure their products meet the highest safety standards.
Our mission is singular – safety of medical devices and IVD products
Our mission is singular – safety of medical devices and IVD products
SERVICES
➕ Biological Evaluation Report (BER)
➕ E/L study for Medical Devices : In-house ISO 10993-18
➕Toxicological Risk Assessment (TRA
➕ Clinical Evaluation Report (CER) for IVD/Medical Devices
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