Patient safety is a major challenge for medical devices.
Manufacturers of these devices and participants in the supply chain are addressed by many UNE healthcare standards, which also help implementing organisations to achieve SDG 3:health and wellbeing.
Some of most sought-after ISO standards are:
- UNE-EN ISO 13485:2018 and its amendment UNE-EN ISO 13485:2018/A11:2022. It facilitates the implementation of quality management systems for any company involved in the supply chain for medical devices.
- UNE-EN ISO 14971:2020 and its amendment UNE-EN ISO 14971:2020/A11:2022. Its purpose is to monitor the risks associated with medical devices during their life cycle.