BS EN ISO 13485:2016 pdf free.Medical devices - Quality management systems - Requirements for regulatory purposes. This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and...
BS EN ISO 15223-1:2016 pdf free
BS EN ISO 15223-1:2016 pdf free.Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part1:General requirements. This document addresses the presentation of certain items of information that are considered by regulatory authorities to be essential for the safe and proper use of medical devices. As such, the items are required to...
BS EN ISO 14971:2009 pdf free
BS EN ISO 14971 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this International Standard are applicable to all stages of the life-cycle of a...
BS EN ISO 14971:2012 pdf free
BS EN ISO 14971:2012 pdf free.Medical devices - Application of risk management to medical devices. The requirements contained in this International Standard provide manufacturers with a framework within which experience, insight and judgment are applied systematically to manage the risks associated with the use of medical devices. This International Standard was developed specifically for medical device/system manufacturers using established principles...
BS EN ISO 13485:2003 pdf free
BS EN ISO 13485:2003 pdf free.Medical devices - Quality management systems - Requirements for regulatory purposes. BS EN ISO 13485 specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services. It can also be used...