Analytical Chemist Appointment to IS0 10993 Committee
Medical Engineering Technologies’ Analytical Chemistry Manager has joined the technical team working on the chemical characterisation aspects of the biocompatibility standard ISO 10993-18.
Luminita Moraru says that she is thrilled to join the conversation and hopes that her practical strength will benefit the committee and those using the standards. She has daily experience applying part 18 and performing extractables studies in order to help clients demonstrate the safety of their devices. Obtaining test extracts from complicated or large devices can be challenging. Then the analysis of complex mixtures of materials also requires thorough and careful method development. When it comes to more invasive and long term devices, laboratory chemical characterisation really does become the most economical and fastest route to market. But, it has to be done properly. The toxicological risk analysis can only be as accurate as the information supplied to the toxicologist.
Lumi and her team have experience working with combination devices, implants and a wide range of medical devices. Get in touch to find out how to answer your biocompatibility questions.