Toxicology & Applied Science

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Toxicology & Applied Science

Toxicology & Applied Science

Category: Quality management systems (QMS)

A quality management system (QMS) is a formal framework of documented policies, procedures, processes, and records that an organization uses to consistently meet customer expectations and regulatory requirements. Its core purpose is to guide an organization in achieving its quality goals, enhancing customer satisfaction, improving efficiency, reducing waste, and fostering continuous improvement in its products and services. The international standard ISO 9001 provides a well-known set of requirements and guidelines for a QMS.

Safety risk categorization for organic extractables and manufacturing aid constituents

Medical matters has developed a risk management (RM) tool that allows to calculate risk scores for chemical constituents. Risk scores are based amongst others on a constituent’s physicochemical properties and its quantitative structure-activity relationship (QSAR) assessment outcomes. Risk scores therefore reflect the patient safety risk posed by a detected leachable/extractable or any other constituent, by consideration of […]

QMS: Entanglement of biological safety and hazardous substance assessments

The compliance of medical devices with hazardous substance regulations and ensuring their biological safety are entangled tasks. At Medical Matters, biological safety and hazardous substance assessments are therefore strongly interlinked. If the portfolio of a medical devices manufacturer includes an article with an identified hazardous substance above the 0.1% (w/w) MDR limit, regulatory obligations get […]