In Vitro Diagnostics Clinical Evaluation

If you manufacture diagnostic devices (such as Sphygmomanometers, stethoscopes, thermometers, ophthalmoscopes, otoscopes), diagnostic reagents, diagnostic kits (including in-home testing devices), the experts at 2SD TS can provide assistance. Our team includes CLIA high complexity laboratory directors who are well-equipped to help you with your needs.

Biocompatibility and safety assessment of the device per FDA and ISO 10993-1 guidance

Assay validation plan for determination of specificity, accuracy, precision, limit of detection, and range verification

Clinical evaluation report (CER)

Preparation of 510(k) submission package for FDA clearances