The “Entreprise Citoyenne TM” label is awarded on the basis of prior certification to ISO 9001 (quality management system) and ISO 14001 (environmental management system) standards. A “Entreprise Citoyenne” is one that takes social and environmental considerations into account in its activities and in its relations. It is therefore an organization whose economic, environmental and social goals coexist, while demonstrating that the pursuit of financial profit is not its sole objective.
Atmospheric preconditioning simulates the effects of different temperature and humidity levels on packages and products. It’s often used to evaluate the performance and durability of packaging materials and products under various environmental conditions.
ISO 9001 is a globally recognized standard for quality management. It helps organizations of all sizes and sectors to improve their performance, meet customer expectations and demonstrate their commitment to quality. Its requirements define how to establish, implement, maintain, and continually improve a quality management system (QMS).
Certain regulatory bodies require a toxicological assessment of extractables and leachables, for certain products, to establish the device’s safety limits of these impurities. ISO 10993-17:2023 specifies the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.
At Medistri, we’re focused on using our resources to combat climate change. We believe our commitments are both ambitious and necessary. To achieve our objectives, we focus on scalable innovation. Designing and implementing new technologies, mobilising financing structures, and rapidly deploying renewable energy.
Risk mitigation through testing in the biocompatibility scenario is a crucial step in the evaluation of medical devices. It involves assessing the biocompatibility of the materials and processes used in the device by taking a risk-based approach to their biological safety evaluations.