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 […]
Weight-of-evidence implementation for biocompatibility assessments
Biocompatibility Evaluation; Biological safety assessment. Regulatory guidances for biological safety describe biocompatibility evaluations of medical devices as a risk-based approach. However, they do not provide specific guidance on how to incorporating a holistic review of all the available data into a risk assessment. One of the major factors contributing to the difficulty of reviewing biocompatibility evaluations for market approval […]
Regulatory framework: Release of FDA Guidance for Use of International Standard ISO 10993-1
FDA has updated their guidance document on ISO 10993-1 to assist industry in preparing regulatory submissions. It incorporates several considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, recommendations for biocompatibility test article preparation for devices with submicron or nanotechnology components and for devices made from in […]