Поиск

Quality systems — Medical devices — Guidance on the application of ISO 13485 and ISO 13488

Medical devices — Quality management systems — Requirements for regulatory purposes

Overview ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes - specifies requirements for a quality management system (QMS) for organizations that des…

Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003

Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirem…

What is PD CEN/TR 17223 - Relationship between EN ISO 13485: 2016 and European and in vitro diagnostic medical devices regulation about? PD CEN/TR 17223 discusses the relationship between EN ISO 1348…

Medical devices. Quality management systems. Guidance on the application of ISO 13485:2003

Giving you support and advice in the implementation of a quality management system for medical devices This Technical Report provides guidance for the application of BS EN ISO 13485. It can be used t…

Medical devices. Quality management systems. Requirements for regulatory purposes.