ISO13485:2016Medical devices – quality management systems

A number of management standards are applicable to medical device manufacturing, with a key one being ISO 13485 – the quality management system specifically designed for medical device manufacturers. It expands on the established ISO 9001, and works to ensure that organisations comply with quality control, traceability, process validation and risk management.

Filtermist helps to ensure the cleanest production facilities possible

Medical device manufacturing covers a wide range of sectors from orthopaedics and dental instruments and technologies, through to diagnostic apparatus, anaesthesia and airway products, and blood transfusion and IV equipment.

The industry utilises a range of manufacturing processes – all of which pose a potential risk to employee health, as well as to product quality and worker productivity.

Filtermist provides a range of products and services to some of the world’s largest medical device manufacturers to help them achieve clean, productive working environments.

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