Luminita Moraru, analytical chemistry manager at Medical Engineering Technologies [MET] has been appointed to the technical team working on the chemical characterisation aspects of the biocompatibility standard ISO 10993-18.
A delighted Moraru said that she relished the opportunity to join the conversation and hoped that her practical strength could bring great benefit to the committee and others utilising the standards.
Moraru has extensive experience from her MET role applying part 18 and performing extractables studies to help clients demonstrate the safety of their devices.
MET managing director, Mark Turner, commented: “Luminita and her team have experience working with combination devices, implants and a wide range of medical devices, in an industry where obtaining test extracts from such devices can be a challenge.
“Analysis of complex mixtures of materials 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 must be done properly. The toxicological risk analysis can only be as accurate as the information supplied to the toxicologist.”
Photo by National Cancer Institute on Unsplash
