ISO 13485 2016
is a global quality management standard for medical
Use it to establish a quality management system that is oriented towards the design,
development, production, and installation of medical devices and related services.
Use it to become certified (registered) and to demonstrate your ability to supply
medical devices and related services that meet customer requirements.
ISO 14971 2007 LIBRARY
ISO 14971 is a risk management
standard for medical devices. It defines
a set of risk management requirements. The purpose of ISO 14971 is to help
manufacturers to establish a medical device risk management process that
they can use to identify hazards, to estimate and evaluate risks, and to
implement and monitor the effectiveness of risk control measures.
ISO 13485 2003 ARCHIVE