2020 Medical Design & Manufacturing West Presentation

Regulatory agencies continue to be more stringent on evaluating impact of particulate matter on medical devices. Particles present unintentionally are considered particulate matter and on medical devices (e.g. implantable) may pose potential risks to patients in contact. The quantity, size and shape of particulate matter, along with the chemical composition of the particles all contribute to the risk level. The source of particulate matter may include raw materials, manufacturing components, packaging processes, and contamination. EAG Laboratories can provide data on the quantity, size and chemical characterization of particulate matter, and propose solutions to reduce particle matter.