SAXOCON are able to provide early support in design control of medical devices by assisting clients with the screening review and selection of robust candidates for construction materials to meet relevant safety requirements for medical devices. We evaluate chemical constituents including preservatives, antioxidant, colourants, UV filters, additives, solvents, lubricants and other functional ingredients. Through this, we can identify undesirable material components and select those with the most appropriate compatibility and functionality for the overall design and development of the medical device.
Using SAXOCON’s team of dedicated Toxicologists and Computational Toxicology experts, we provide our clients with best practice toxicological risk assessments to evaluate and qualify any relevant compounds resulting from extractable/leachable studies to which the patients or users may be exposed. We have collective experiences across the pharmaceutical, medical device, chemical and consumer industries. Through a combination of relevant technical, scientific and regulatory aspects of material safety, literature searches, toxicology databases as well as computer models such as (Q)SAR ((Quantitative) Structure-Activity Relationship) models and read-across analysis., we compile comprehensive toxicological profiles of chemical substances and mixtures relevant for risk assessment of device materials.
In addition, we can perform risk assessments to demonstrate the acceptable presence of these substances via various routes of administration and exposure scenarios. We can further provide recommendations for potential replacement or alternative ingredients/materials during product reformulation or when qualifying new manufacturers and suppliers of materials and components.