Biological Evaluation of Medical Devices according to ISO 10993 Standards
We perform categorization of medical devices to select the appropriate nonclinical tests to perform, taking into account the type, degree and duration of contact of the medical device with the body, as well as the toxicological profile of the substances present in the final product and the amount of such substances that can be available to the human body.
Management and Monitoring of Nonclinical Studies
Our management and monitoring activities usually include involvement on study design,  selection of suitable CROs around the world (considering expertise, slots and prices),  requests for cost estimates to CROs,  definition and critical review of protocol to ensure regulatory compliance, management tasks, direct communication with study directors, follow-up / monitoring of all study activities, coordination of tasks in multisite studies, assistance on any decisions along the study and Critical review of the study report.
Toxicological Data Searches
Available toxicological information on databases / bibliography can serve to characterize risks associated to the different substances present in a medical device. In certain cases where appropriate information is available, waivers for the conduct of toxicity studies can be adequately justified. We perform thorough searches and qualified assessment on the available data to avoid conducting unnecessary toxicity studies.
Medical Devices Incorporating a Medicinal Substance with Ancillary Action
Medicinal substances incorporated in a medical device with ancillary actions can be either new substances, known substances intended for well established purposes or known substances intended for a non-previously established purpose. We evaluate the available data and advise on the need for performing nonclinical studies supporting regulatory requirements for both medical devices and medicinal products. Likewise, we can prepare the documentation with the appropriate data to submit to Notified Bodies and competent authorities for medicinal products.