The medical device industry is a crucial segment of the healthcare sector, involved in the design, manufacture, and marketing of devices that diagnose, prevent, monitor, treat, or alleviate diseases and health conditions. This industry includes a wide range of products, from simple bandages and spectacles to complex programmable pacemakers and sophisticated imaging systems.

Key ISO Standards Relevant to the Medical Device Industry

ISO 13485: Medical Devices – Quality Management Systems

ISO 13485 is the principal standard for quality management systems in the medical device industry. It is designed to work throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal. This standard focuses on what manufacturers must do to ensure their devices consistently meet customer and regulatory requirements.

ISO 14971: Medical Devices – Application of Risk Management to Medical Devices

ISO 14971 provides a thorough framework for manufacturers to identify hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, estimate and evaluate associated risks, control these risks, and monitor the effectiveness of the controls. The purpose of risk management is to ensure that the medical device is as safe as possible, and it plays a crucial role in the product life cycle.