EMDT adds biological evaluations to support biocompatibility strategies

Geoffrey Moodie, PhD, Director, Biocompatibility, Eurofins Medical Device Testing

The Toxicology Team in Lancaster has historically offered toxicological risk assessments of extractable/leachable data from medical devices and pharmaceutical packaging. Over the last few years, we added biological evaluation plans and reports to our offering to help clients in developing biocompatibility strategies and documentation compliant with current standards.

Most recently we’ve formalized our consulting offerings for clients who need more targeted help. For example, they may have a material change in their product and need to understand, mitigate, and document the biological risk due to this change. Another example is a failed cytotoxicity test, a situation any clients unexpectedly find themselves in and are unclear on how to navigate. Perhaps a client has prepared their own biocompatibility documentation but lacks a qualified individual to review these materials. Or they may have a series of tests that had been performed some time ago and need to know if here are significant gaps relative to current expectations.

This consultation can take many forms. It may simply be phone calls with the clients, writing rationales for submission to regulatory agencies, reviewing documents prepared by clients, or modifying existing documents to accommodate design changes. Given this variety, the service offered to the client can be tailored to their specific needs.

This new service offering allows us to forge relationships with new clients and enhance existing client partnerships. To ensure each project meets individual client requirements, each of these will be evaluated case-by-case by our team. For this type of customizable offering, quoting will also be done specific to each project. Adding biological evaluations are yet another step to delivering enhanced value to our clients.