A quality management system “where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements”: this is what ISO 13485 certifies, which Predict achieved in March 2019.
The international standard UNI EN ISO 13485:2016 enhances the role of the quality management system (QMS) within the company, as a guarantor of compliance with the highest standards of safety and efficacy of electro-medical equipment at all stages of the process: from planning to production, from marketing to after-sales service. In each phase, specific risk analysis and management protocols and strict compliance monitoring systems are provided for.
The adoption of the ISO 13485 standard represents a turning point for Predict.
After obtaining the CE product certification for the new medical device Mistral, the Apulian company is ready for the challenge of launching this innovative device for the early detection of cancer. This is thanks to a robust vigilance system along the entire supply chain: upstream (with the control of suppliers) and downstream (with the collection of post sales feedback).
The EU directives on electro-medical devices are very stringent indeed. This is why our company enthusiastically welcomes the achievement of ISO 13485:2016 certification: it is the confirmation of a constant commitment to the safety and quality of the device.