Solution-focused toxicological risk assessment and medical device biocompatibility consulting

Toxicological Data Assessment Consulting, LLC (TDAC) specializes in medical device toxicological risk assessment and biocompatibility solutions to ensure compliance with ISO 10993 standards. We offer timely, high quality, and cost effective services in the medical device area. No project is too small, and we are able to accommodate urgent requests.

Our main service areas include:

• Toxicological Risk Assessment (TRA) reports (ISO 10993-17, ISO 18562, and ICH Q3E)
• Analytical chemistry consulting (study design, protocol review, data interpretation)
• Biocompatibility support (biological evaluation plans and reports, gap analysis)
• Regulatory support (strategy development, interactive meetings, deficiency responses)

TDAC’s board certified toxicologist has a proven track record with over 28 years of toxicological risk assessment experience. TDAC has successfully prepared more than 272 TRAs and Biological Evaluation Reports, obtaining regulatory clearances of medical device submissions such as 510(k) from US FDA, CE mark approval under EU MDR, and approvals from Japan PMDA and China. 

If you are interested in our services, please refer to the GET STARTED menu.