Regulations impose increasingly stringent requirements at every stage of a product's lifecycle, including service and delivery. Organizations must be able to demonstrate the effectiveness of their quality management processes and implement best practices in all of their activities. ISO 13485, an internationally recognized standard, establishes the requirements for a quality management system specific to the medical devices sector
More information on the ISO website
qmt demonstrates, through its ISO13485 certification, recognized expertise in the development and implementation of quality control systems for the medical sector. The requirements of ISO 13485 apply to companies designing control systems for use in medical devices. All along the value chain, qmt products are designed, developed and manufactured with the aim of being safer and more efficient. Particular rigor is applied to the traceability and risk analysis of vision systems intended for the medical sector. The risk analysis is integrated into the risk management file of the product object. The formal validation of the software according to GAMP (Good Automated Manufacturing Practice) or other must be detailed and transmitted.